Trial Outcomes & Findings for Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED) (NCT NCT00442897)
NCT ID: NCT00442897
Last Updated: 2024-05-22
Results Overview
Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
229 participants
Primary outcome timeframe
After 6 weeks of treatment
Results posted on
2024-05-22
Participant Flow
Patient were recruited between September 2006 and May 2008.
Patients who were naïve to lipid-lowering agent or patients who were treated with lipid-lowering agent and had 4 week' wash-out period were enrolled in the study. The eligible patients will be allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio.
Participant milestones
| Measure |
Vytorin
Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C \< 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
|
Atorvastatin
Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
|
|---|---|---|
|
Base Study (12 Week Follow-up)
STARTED
|
118
|
111
|
|
Base Study (12 Week Follow-up)
COMPLETED
|
101
|
99
|
|
Base Study (12 Week Follow-up)
NOT COMPLETED
|
17
|
12
|
|
24 Weeks Follow-up (3 Centers)
STARTED
|
35
|
34
|
|
24 Weeks Follow-up (3 Centers)
COMPLETED
|
29
|
28
|
|
24 Weeks Follow-up (3 Centers)
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Vytorin
Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C \< 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
|
Atorvastatin
Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
|
|---|---|---|
|
Base Study (12 Week Follow-up)
Adverse Event
|
1
|
0
|
|
Base Study (12 Week Follow-up)
Death
|
0
|
1
|
|
Base Study (12 Week Follow-up)
Protocol Violation
|
7
|
3
|
|
Base Study (12 Week Follow-up)
Withdrawal by Subject
|
9
|
8
|
|
24 Weeks Follow-up (3 Centers)
Adverse Event
|
1
|
0
|
|
24 Weeks Follow-up (3 Centers)
Lost to Follow-up
|
2
|
2
|
|
24 Weeks Follow-up (3 Centers)
Protocol Violation
|
2
|
1
|
|
24 Weeks Follow-up (3 Centers)
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Vytorin
n=118 Participants
Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C \< 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
|
Atorvastatin
n=111 Participants
Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.89 years
STANDARD_DEVIATION 9.28 • n=99 Participants
|
61.74 years
STANDARD_DEVIATION 9.94 • n=107 Participants
|
61.30 years
STANDARD_DEVIATION 9.59 • n=206 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata
LDL-C 130-159mg/dl
|
64 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata
LDL-C 160-189mg/dl
|
38 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata
LDL-C >=190mg/dl
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata
LDL-C <130mg/dl
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Baseline values for Apolipoprotein B (Apo B)
|
113.23 mg/dL
STANDARD_DEVIATION 30.97 • n=99 Participants
|
110.63 mg/dL
STANDARD_DEVIATION 31.63 • n=107 Participants
|
111.97 mg/dL
STANDARD_DEVIATION 31.25 • n=206 Participants
|
|
Baseline values for High-Density Lipoprotein Cholesterol (HDL-C)
|
48.23 mg/dL
STANDARD_DEVIATION 10.25 • n=99 Participants
|
48.9 mg/dL
STANDARD_DEVIATION 13.01 • n=107 Participants
|
48.55 mg/dL
STANDARD_DEVIATION 11.65 • n=206 Participants
|
|
Baseline values for LDL-C:HDL-C
|
3.54 Ratio
STANDARD_DEVIATION 1.13 • n=99 Participants
|
3.54 Ratio
STANDARD_DEVIATION 1.04 • n=107 Participants
|
3.54 Ratio
STANDARD_DEVIATION 1.08 • n=206 Participants
|
|
Baseline values for Low-Density Lipoprotein Cholesterol(LDL-C)
|
164.11 mg/dL
STANDARD_DEVIATION 33.52 • n=99 Participants
|
162.56 mg/dL
STANDARD_DEVIATION 26.75 • n=107 Participants
|
163.36 mg/dL
STANDARD_DEVIATION 30.37 • n=206 Participants
|
|
Baseline values for Non HDL-C
|
191.54 mg/dL
STANDARD_DEVIATION 38.25 • n=99 Participants
|
190.72 mg/dL
STANDARD_DEVIATION 31.11 • n=107 Participants
|
191.14 mg/dL
STANDARD_DEVIATION 34.88 • n=206 Participants
|
|
Baseline values for Total Cholesterol (TC)
|
241.4 mg/dL
STANDARD_DEVIATION 39.53 • n=99 Participants
|
239.58 mg/dL
STANDARD_DEVIATION 30.86 • n=107 Participants
|
240.51 mg/dL
STANDARD_DEVIATION 35.51 • n=206 Participants
|
|
Baseline values for Triglycerides (TG)
|
142 mg/dL
STANDARD_DEVIATION 86.27 • n=99 Participants
|
144 mg/dL
STANDARD_DEVIATION 57.34 • n=107 Participants
|
143 mg/dL
STANDARD_DEVIATION 73.69 • n=206 Participants
|
|
Body Mass Index (BMI)
|
24.97 Kg/m2
STANDARD_DEVIATION 2.92 • n=99 Participants
|
24.86 Kg/m2
STANDARD_DEVIATION 2.64 • n=107 Participants
|
24.92 Kg/m2
STANDARD_DEVIATION 2.78 • n=206 Participants
|
|
Body Weight
|
64.61 Kilograms (Kg)
STANDARD_DEVIATION 9.78 • n=99 Participants
|
64.40 Kilograms (Kg)
STANDARD_DEVIATION 10.51 • n=107 Participants
|
64.51 Kilograms (Kg)
STANDARD_DEVIATION 10.12 • n=206 Participants
|
|
Diastolic Blood Pressure
|
75.86 mm Hg
STANDARD_DEVIATION 10.16 • n=99 Participants
|
77.74 mm Hg
STANDARD_DEVIATION 10.53 • n=107 Participants
|
76.77 mm Hg
STANDARD_DEVIATION 15.98 • n=206 Participants
|
|
Systolic Blood Pressure
|
126.44 mm Hg
STANDARD_DEVIATION 15.23 • n=99 Participants
|
129.53 mm Hg
STANDARD_DEVIATION 16.65 • n=107 Participants
|
127.94 mm Hg
STANDARD_DEVIATION 15.98 • n=206 Participants
|
PRIMARY outcome
Timeframe: After 6 weeks of treatmentPopulation: The analysis used all patient treated (APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.
Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)
Outcome measures
| Measure |
Vytorin
n=107 Participants
Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C \< 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
|
Atorvastatin
n=101 Participants
Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
|
|---|---|---|
|
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
|
89 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: After 12 weeks of the treatmentPopulation: All patient treated (APT) approach
If patients didn't achieve LDL-C \<100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.
Outcome measures
| Measure |
Vytorin
n=107 Participants
Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C \< 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
|
Atorvastatin
n=101 Participants
Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
|
|---|---|---|
|
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment
|
85 Participants
|
63 Participants
|
Adverse Events
Vytorin
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Atorvastatin
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vytorin
n=108 participants at risk
Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C \< 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
|
Atorvastatin
n=103 participants at risk
Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
2.9%
3/103 • Number of events 3
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
Other adverse events
| Measure |
Vytorin
n=108 participants at risk
Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C \< 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
|
Atorvastatin
n=103 participants at risk
Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
4/108 • Number of events 4
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Infections and infestations
Nasopharyngitis
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
1.9%
2/103 • Number of events 3
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Infections and infestations
Urinary tract infection
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Infections and infestations
Cystitis
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Infections and infestations
Headache
|
1.9%
2/108 • Number of events 2
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Nervous system disorders
Dizziness
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Cardiac disorders
Angina pectoris
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Cardiac disorders
Palpitations
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
General disorders
Asthenia
|
0.93%
1/108 • Number of events 2
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
General disorders
Oedema
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
General disorders
Generalized oedema
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
1.9%
2/103 • Number of events 2
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
General disorders
Application site reaction
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
General disorders
Pyrexia
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Eye disorders
Glaucoma
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
1.9%
2/103 • Number of events 2
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
1.9%
2/103 • Number of events 2
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
1.9%
2/103 • Number of events 2
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Investigations
Transaminases increased
|
1.9%
2/108 • Number of events 2
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Surgical and medical procedures
Skin lesion excision
|
0.93%
1/108 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.00%
0/103
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Skin and subcutaneous tissue disorders
Skin inflammation
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/108
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
0.97%
1/103 • Number of events 1
Total of 229 patients were randomized in this study, but 18 patients were excluded in safety evaluation. Because 17 of them didn't take any study medication (vytorin or atorvastatin) after randomization and one of them couldn't categorize in any group.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER