Trial Outcomes & Findings for Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension (NCT NCT00841672)
NCT ID: NCT00841672
Last Updated: 2011-07-12
Results Overview
Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
485 participants
Primary outcome timeframe
Baseline to end of study (Week 8)
Results posted on
2011-07-12
Participant Flow
Participant milestones
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
241
|
|
Overall Study
COMPLETED
|
224
|
209
|
|
Overall Study
NOT COMPLETED
|
20
|
32
|
Reasons for withdrawal
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
16
|
|
Overall Study
Abnormal test procedure result(s)
|
0
|
1
|
|
Overall Study
Subject withdrew consent
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Administrative problems
|
9
|
9
|
|
Overall Study
Misrandomized
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
n=244 Participants
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
n=241 Participants
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
Total
n=485 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59 years
STANDARD_DEVIATION 10.38 • n=5 Participants
|
59 years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
59 years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues
Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)
Outcome measures
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
n=233 Participants
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
n=230 Participants
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
Mean Sitting Systolic Blood Pressure (msSBP)
|
-37.72 mm Hg
Standard Error 0.937
|
-30.63 mm Hg
Standard Error 0.941
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues
Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)
Outcome measures
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
n=233 Participants
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
n=230 Participants
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
Mean Sitting Diastolic Blood Pressure (msDBP)
|
-16.10 mm Hg
Standard Error 0.557
|
-12.27 mm Hg
Standard Error 0.559
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full Analysis Set - analysis set was the FAS excluding patients from one center due to GCP issues
Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP \< 140 mmHg or a reduction =\> 20 mmHg from the baseline) from baseline to end of study (Week 8)
Outcome measures
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
n=233 Participants
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
n=230 Participants
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
Systolic Blood Pressure Response
|
88.8 Percentage of participants
|
79.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues All randomized patients who received the study medication. The measurement at Week 8 was used unless it was not available, in which case, the last observation carried forward was used.
Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP \< 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)
Outcome measures
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
n=233 Participants
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
n=230 Participants
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
Diastolic Blood Pressure Response
|
92.7 Percentage of participants
|
86.5 Percentage of participants
|
SECONDARY outcome
Timeframe: End of study (Week 8)Population: Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues
Percentage of patients achieving blood pressure control (msSBP \< 140 mm Hg and msDBP \< 90 mm Hg) at end of study
Outcome measures
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
n=233 Participants
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
n=230 Participants
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
Blood Pressure Control
|
67.0 Percentage of participants
|
49.1 Percentage of participants
|
Adverse Events
Aliskiren/Amlodipine 300/10 mg Tablet
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Amlodipine 10 mg Capsule
Serious events: 3 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
n=243 participants at risk
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
n=241 participants at risk
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/243
|
0.41%
1/241
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/243
|
0.41%
1/241
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/243
|
0.41%
1/241
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/243
|
0.41%
1/241
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/243
|
0.41%
1/241
|
Other adverse events
| Measure |
Aliskiren/Amlodipine 300/10 mg Tablet
n=243 participants at risk
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
|
Amlodipine 10 mg Capsule
n=241 participants at risk
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
14.4%
35/243
|
18.3%
44/241
|
|
Nervous system disorders
Headache
|
3.3%
8/243
|
5.4%
13/241
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER