Trial Outcomes & Findings for Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients (NCT NCT01190007)
NCT ID: NCT01190007
Last Updated: 2021-01-28
Results Overview
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
159 participants
Primary outcome timeframe
52 weeks
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
Caduet
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Overall Study
STARTED
|
159
|
|
Overall Study
COMPLETED
|
145
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Caduet
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Difficulty of visit for complications
|
1
|
|
Overall Study
Participant was arrested
|
1
|
Baseline Characteristics
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
Baseline characteristics by cohort
| Measure |
Caduet
n=159 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
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|---|---|
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Age, Continuous
|
65.0 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The safety analysis set included all participants who took at least one dose of study drug.
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Outcome measures
| Measure |
Caduet
n=159 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
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|---|---|
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE
|
120 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAE
|
11 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
Value at each visits minus value at baseline
Outcome measures
| Measure |
Caduet
n=142 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
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|---|---|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 2 (n=140)
|
-0.2 mmHg
Standard Deviation 8.57
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 4 (n=139)
|
-0.6 mmHg
Standard Deviation 9.19
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 8 (n=140)
|
0.0 mmHg
Standard Deviation 10.38
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 12 (n=140)
|
-0.4 mmHg
Standard Deviation 10.46
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 16 (n=138)
|
-1.5 mmHg
Standard Deviation 11.10
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 20 (n=136)
|
-2.8 mmHg
Standard Deviation 10.07
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 24 (n=134)
|
-1.8 mmHg
Standard Deviation 9.74
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 28 (n=132)
|
-3.1 mmHg
Standard Deviation 10.39
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 32 (n=132)
|
-4.8 mmHg
Standard Deviation 10.76
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 36 (n=132)
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-4.8 mmHg
Standard Deviation 8.85
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 40 (n=132)
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-4.4 mmHg
Standard Deviation 8.84
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 44 (n=130)
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-4.0 mmHg
Standard Deviation 10.58
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 48 (n=130)
|
-2.3 mmHg
Standard Deviation 10.20
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 52 (n=129)
|
-1.5 mmHg
Standard Deviation 10.92
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 52 (LOCF) (n=142)
|
-1.5 mmHg
Standard Deviation 10.81
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SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. Participants both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.
Value at each visits minus value at baseline
Outcome measures
| Measure |
Caduet
n=16 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
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|---|---|
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Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 2 (n=15)
|
-1.1 mmHg
Standard Deviation 11.57
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 4 (n=16)
|
-2.3 mmHg
Standard Deviation 8.68
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 8 (n=16)
|
-1.1 mmHg
Standard Deviation 7.76
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 12 (n=16)
|
-2.2 mmHg
Standard Deviation 9.11
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 16 (n=16)
|
-2.3 mmHg
Standard Deviation 13.49
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 20 (n=16)
|
-2.3 mmHg
Standard Deviation 8.47
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 24 (n=16)
|
-6.7 mmHg
Standard Deviation 9.07
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 28 (n=16)
|
-6.8 mmHg
Standard Deviation 10.23
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 32 (n=16)
|
-7.8 mmHg
Standard Deviation 10.79
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 36 (n=15)
|
-5.7 mmHg
Standard Deviation 9.72
|
|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 40 (n=15)
|
-2.7 mmHg
Standard Deviation 10.00
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 44 (n=15)
|
-3.7 mmHg
Standard Deviation 11.38
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 48 (n=15)
|
-0.4 mmHg
Standard Deviation 9.44
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 52 (n=15)
|
-4.4 mmHg
Standard Deviation 13.08
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|
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Week 52 (LOCF) (n=16)
|
-3.1 mmHg
Standard Deviation 13.77
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
Value at each visits minus value at baseline
Outcome measures
| Measure |
Caduet
n=142 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
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|---|---|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 2 (n=140)
|
0.3 mmHg
Standard Deviation 7.03
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 4 (n=139)
|
-0.4 mmHg
Standard Deviation 6.75
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 8 (n=140)
|
0.2 mmHg
Standard Deviation 6.90
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 12 (n=140)
|
-0.2 mmHg
Standard Deviation 7.13
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 16 (n=138)
|
-0.7 mmHg
Standard Deviation 7.50
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|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 20 (n=136)
|
-1.8 mmHg
Standard Deviation 7.38
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|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 24 (n=134)
|
-1.6 mmHg
Standard Deviation 7.03
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 28 (n=132)
|
-2.6 mmHg
Standard Deviation 7.27
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 32 (n=132)
|
-3.5 mmHg
Standard Deviation 7.84
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 36 (n=132)
|
-4.3 mmHg
Standard Deviation 6.50
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 40 (n=132)
|
-3.2 mmHg
Standard Deviation 6.90
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 44 (n=130)
|
-2.5 mmHg
Standard Deviation 7.40
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 48 (n=130)
|
-2.0 mmHg
Standard Deviation 7.52
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 52 (n=129)
|
-0.6 mmHg
Standard Deviation 7.72
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Week 52 (LOCF) (n=142)
|
-0.6 mmHg
Standard Deviation 7.68
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. Participants with both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.
Value at each visits minus value at baseline
Outcome measures
| Measure |
Caduet
n=16 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 2 (n=15)
|
0.8 mmHg
Standard Deviation 8.21
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 4 (n=16)
|
-1.1 mmHg
Standard Deviation 4.96
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 8 (n=16)
|
-1.0 mmHg
Standard Deviation 6.19
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 12 (n=16)
|
-1.1 mmHg
Standard Deviation 6.86
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 16 (n=16)
|
-2.2 mmHg
Standard Deviation 7.12
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 20 (n=16)
|
-0.9 mmHg
Standard Deviation 6.71
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 24 (n=16)
|
-3.5 mmHg
Standard Deviation 6.69
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 28 (n=16)
|
-3.0 mmHg
Standard Deviation 6.55
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 32 (n=16)
|
-4.8 mmHg
Standard Deviation 9.56
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 36 (n=15)
|
-2.5 mmHg
Standard Deviation 6.20
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 40 (n=15)
|
-1.2 mmHg
Standard Deviation 8.53
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 44 (n=15)
|
-2.6 mmHg
Standard Deviation 9.06
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 48 (n=15)
|
-0.7 mmHg
Standard Deviation 5.18
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 52 (n=15)
|
-4.4 mmHg
Standard Deviation 6.75
|
|
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Week 52 (LOCF) (n=16)
|
-3.2 mmHg
Standard Deviation 8.29
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Outcome measures
| Measure |
Caduet
n=157 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
Week 4 (n=157)
|
-10.9 Percentage of LDL-C
Standard Deviation 23.87
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
Week 12 (n=155)
|
-7.4 Percentage of LDL-C
Standard Deviation 25.66
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
Week 24 (n=151)
|
-10.5 Percentage of LDL-C
Standard Deviation 24.04
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
Week 52 (n=144)
|
-12.3 Percentage of LDL-C
Standard Deviation 23.62
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
Week 52 (LOCF) (n=156)
|
-12.2 Percentage of LDL-C
Standard Deviation 23.55
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Outcome measures
| Measure |
Caduet
n=157 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
Week 4 (n=157)
|
-7.3 Percentage of TC
Standard Deviation 15.90
|
|
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
Week 12 (n=156)
|
-5.0 Percentage of TC
Standard Deviation 17.03
|
|
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
Week 24 (n=151)
|
-7.9 Percentage of TC
Standard Deviation 16.78
|
|
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
Week 52 (n=145)
|
-8.0 Percentage of TC
Standard Deviation 16.37
|
|
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
Week 52 (LOCF) (n=157)
|
-8.1 Percentage of TC
Standard Deviation 16.04
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Outcome measures
| Measure |
Caduet
n=157 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 4 (n=157)
|
1.5 Percentage of HDL-C
Standard Deviation 10.63
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 12 (n=156)
|
4.0 Percentage of HDL-C
Standard Deviation 13.91
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 24 (n=151)
|
-0.5 Percentage of HDL-C
Standard Deviation 13.26
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 52 (n=145)
|
2.2 Percentage of HDL-C
Standard Deviation 11.47
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 52 (LOCF) (n=157)
|
2.5 Percentage of HDL-C
Standard Deviation 11.69
|
SECONDARY outcome
Timeframe: Week 4, 12, 24, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Outcome measures
| Measure |
Caduet
n=157 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Percent Change From Baseline in Triglyceride (TG) at Each Visit
Week 4 (n=157)
|
8.2 Percentage of TG
Standard Deviation 52.47
|
|
Percent Change From Baseline in Triglyceride (TG) at Each Visit
Week 12 (n=156)
|
3.6 Percentage of TG
Standard Deviation 49.94
|
|
Percent Change From Baseline in Triglyceride (TG) at Each Visit
Week 24 (n=151)
|
6.4 Percentage of TG
Standard Deviation 45.75
|
|
Percent Change From Baseline in Triglyceride (TG) at Each Visit
Week 52 (n=145)
|
8.5 Percentage of TG
Standard Deviation 62.03
|
|
Percent Change From Baseline in Triglyceride (TG) at Each Visit
Week 52 (LOCF) (n=157)
|
7.2 Percentage of TG
Standard Deviation 60.92
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
Value at each visits minus value at baseline
Outcome measures
| Measure |
Caduet
n=157 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 4 (n=157)
|
-0.4 Ratio
Standard Deviation 0.70
|
|
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 12 (n=155)
|
-0.3 Ratio
Standard Deviation 0.70
|
|
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 24 (n=151)
|
-0.3 Ratio
Standard Deviation 0.66
|
|
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 52 (n=144)
|
-0.4 Ratio
Standard Deviation 0.68
|
|
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 52 (LOCF) (n=156)
|
-0.4 Ratio
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
Value at each visits minus value at baseline
Outcome measures
| Measure |
Caduet
n=157 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 4 (n=157)
|
-0.4 Ratio
Standard Deviation 0.77
|
|
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 12 (n=156)
|
-0.4 Ratio
Standard Deviation 0.79
|
|
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 24 (n=151)
|
-0.3 Ratio
Standard Deviation 0.76
|
|
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 52 (n=145)
|
-0.4 Ratio
Standard Deviation 0.77
|
|
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Week 52 (LOCF) (n=157)
|
-0.4 Ratio
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Week 4, 12, 24, and 52Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Outcome measures
| Measure |
Caduet
n=157 Participants
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Percent Change From Baseline in Apolipoprotein B at Each Visit
Week 24 (n=151)
|
-7.4 Percentage of Apolipoprotein B
Standard Deviation 20.99
|
|
Percent Change From Baseline in Apolipoprotein B at Each Visit
Week 4 (n=157)
|
-9.2 Percentage of Apolipoprotein B
Standard Deviation 18.59
|
|
Percent Change From Baseline in Apolipoprotein B at Each Visit
Week 12 (n=156)
|
-5.8 Percentage of Apolipoprotein B
Standard Deviation 21.13
|
|
Percent Change From Baseline in Apolipoprotein B at Each Visit
Week 52 (n=145)
|
-9.1 Percentage of Apolipoprotein B
Standard Deviation 20.10
|
|
Percent Change From Baseline in Apolipoprotein B at Each Visit
Week 52 (LOCF) (n=157)
|
-9.3 Percentage of Apolipoprotein B
Standard Deviation 19.84
|
Adverse Events
Caduet
Serious events: 11 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caduet
n=159 participants at risk
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign soft tissue neoplasm
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Aortic aneurysm
|
0.63%
1/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Caduet
n=159 participants at risk
Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.5%
4/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
5/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
4/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
5/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
6.9%
11/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
3.8%
6/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
53/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
10.7%
17/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
5.7%
9/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
6/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
6/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.5%
4/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.5%
4/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
3.8%
6/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.8%
6/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.0%
8/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.7%
9/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
4/159
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER