Trial Outcomes & Findings for Filtered Trial for Amlodipine Non-responder (NCT NCT00558064)
NCT ID: NCT00558064
Last Updated: 2014-07-08
Results Overview
The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
COMPLETED
PHASE3
531 participants
Baseline and 8 Weeks
2014-07-08
Participant Flow
Participant milestones
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Overall Study
STARTED
|
269
|
262
|
|
Overall Study
COMPLETED
|
264
|
257
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
No visit within allowance period
|
1
|
0
|
Baseline Characteristics
Filtered Trial for Amlodipine Non-responder
Baseline characteristics by cohort
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=269 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=262 Participants
A5 capsule, oral, once daily in the morning
|
Total
n=531 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
56 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
56.5 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=99 Participants
|
186 Participants
n=107 Participants
|
383 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 WeeksPopulation: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=263 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=257 Participants
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)
|
9.56 mmHg
Standard Error 0.61
|
4.45 mmHg
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline and 8 WeeksPopulation: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=263 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=257 Participants
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)
|
13.04 mmHg
Standard Error 0.88
|
5.77 mmHg
Standard Error 0.88
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=263 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=257 Participants
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)
|
68.1 percentage of patients
|
47.1 percentage of patients
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=164 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=179 Participants
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)
|
67.1 percentage of patients
|
45.8 percentage of patients
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Adequate response defined that seated trough diastolic blood pressure was \<90 mmHg or decreased from reference baseline by \>=10 mmHg at 8 weeks
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=263 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=257 Participants
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
|
74.5 percentage of patients
|
50.2 percentage of patients
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Adequate response defined that seated trough systolic blood pressure was \<140 mmHg or decreased from reference baseline by \>=20 mmHg at 8 weeks (0 percent at baseline)
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=263 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=257 Participants
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks
|
79.5 percentage of patients
|
58.4 percentage of patients
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Optimal, normal, high normal blood pressure were defined as follows: * Optimal: Systolic blood pressure (SBP) \< 120 mmHg and diastolic blood pressure (DBP) \< 80 mmHg * Normal: SBP \>= 120 mmHg or DBP \>= 80 mmHg and SBP \< 130 mmHg and DBP \< 85 mmHg * High normal: SBP \>= 130 mmHg or DBP \>= 85 mmHg and SBP \< 140 mmHg and DBP \< 90 mmHg * No: SBP \>= 140 mmHg and DPB \>= 90 mmHg
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=263 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=257 Participants
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
Optimal
|
11.0 percentage of patients
|
1.6 percentage of patients
|
|
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
Normal
|
24.3 percentage of patients
|
9.7 percentage of patients
|
|
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
High Normal
|
26.6 percentage of patients
|
23.0 percentage of patients
|
SECONDARY outcome
Timeframe: First administration of randomised treatment to 24 hours post last dose of randomised treatmentPopulation: Treated set: Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or A5 during the double-blind treatment period.
Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=269 Participants
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=262 Participants
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Blood creatine phosphokinase increased
|
2 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Blood potassium increased
|
0 participants
|
1 participants
|
|
Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Alanine aminotransferase increased
|
1 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Aspartate aminotransferase increased
|
1 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Blood urine present
|
1 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Liver function test abnormal
|
1 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Bradycardia
|
1 participants
|
0 participants
|
Adverse Events
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
Amlodipine 5 mg Monotherapy
Serious adverse events
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=269 participants at risk
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=262 participants at risk
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.37%
1/269 • First administration of randomised treatment to 24 hours post last dose of randomised treatment
|
0.00%
0/262 • First administration of randomised treatment to 24 hours post last dose of randomised treatment
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/269 • First administration of randomised treatment to 24 hours post last dose of randomised treatment
|
0.38%
1/262 • First administration of randomised treatment to 24 hours post last dose of randomised treatment
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/269 • First administration of randomised treatment to 24 hours post last dose of randomised treatment
|
0.38%
1/262 • First administration of randomised treatment to 24 hours post last dose of randomised treatment
|
Other adverse events
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=269 participants at risk
T40/A5 tablet, oral, once daily in the morning
|
Amlodipine 5 mg Monotherapy
n=262 participants at risk
A5 capsule, oral, once daily in the morning
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.3%
25/269 • First administration of randomised treatment to 24 hours post last dose of randomised treatment
|
13.0%
34/262 • First administration of randomised treatment to 24 hours post last dose of randomised treatment
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
- Publication restrictions are in place
Restriction type: OTHER