Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone (NCT NCT00778921)
NCT ID: NCT00778921
Last Updated: 2016-10-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
847 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2016-10-27
Participant Flow
Participant milestones
| Measure |
Aliskiren/Amlodipine 300/10 mg
Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
|
Aliskiren/Amlodipine 150/10 mg
Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
|
Amlodipine 10 mg
Oral capsules of amlodipine 10 mg taken once daily with water in the morning
|
|---|---|---|---|
|
Overall Study
STARTED
|
279
|
285
|
283
|
|
Overall Study
COMPLETED
|
261
|
266
|
255
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
28
|
Reasons for withdrawal
| Measure |
Aliskiren/Amlodipine 300/10 mg
Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
|
Aliskiren/Amlodipine 150/10 mg
Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
|
Amlodipine 10 mg
Oral capsules of amlodipine 10 mg taken once daily with water in the morning
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
10
|
14
|
|
Overall Study
Abnormal Laboratory Value(s)
|
1
|
0
|
0
|
|
Overall Study
Abnormal Test Procedure Result(s)
|
0
|
0
|
2
|
|
Overall Study
Unsatisfactory therapeutic response
|
1
|
1
|
1
|
|
Overall Study
Patient No Longer Requires Study Drug
|
0
|
1
|
0
|
|
Overall Study
Patient withdrew request
|
3
|
1
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
|
Overall Study
Administrative Problems
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
2
|
|
Overall Study
Not treated
|
0
|
2
|
2
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone
Baseline characteristics by cohort
| Measure |
Aliskiren/Amlodipine 300/10 mg
n=279 Participants
Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
|
Aliskiren/Amlodipine 150/10 mg
n=285 Participants
Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
|
Amlodipine 10 mg
n=283 Participants
Oral capsules of amlodipine 10 mg taken once daily with water in the morning
|
Total
n=847 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 10.70 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 10.60 • n=4 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
328 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
519 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: full analysis set
Outcome measures
| Measure |
Aliskiren/Amlodipine 300/10 mg
n=277 Participants
Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
|
Aliskiren/Amlodipine 150/10 mg
n=281 Participants
Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
|
Amlodipine 10 mg
n=279 Participants
Oral capsules of amlodipine 10 mg taken once daily with water in the morning
|
|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
|
-10.99 mm Hg
Standard Error 0.462
|
-8.95 mm Hg
Standard Error 0.460
|
-7.23 mm Hg
Standard Error 0.459
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: full analysis set
Outcome measures
| Measure |
Aliskiren/Amlodipine 300/10 mg
n=277 Participants
Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
|
Aliskiren/Amlodipine 150/10 mg
n=281 Participants
Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
|
Amlodipine 10 mg
n=279 Participants
Oral capsules of amlodipine 10 mg taken once daily with water in the morning
|
|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study
|
-14.42 mm Hg
Standard Error 0.684
|
-11.01 mm Hg
Standard Error 0.681
|
-8.20 mm Hg
Standard Error 0.680
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Analysis: Intention to Treat (ITT) Imputation Technique: Last Observation Carried Forward (LOCF)
Outcome measures
| Measure |
Aliskiren/Amlodipine 300/10 mg
n=279 Participants
Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
|
Aliskiren/Amlodipine 150/10 mg
n=283 Participants
Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
|
Amlodipine 10 mg
n=281 Participants
Oral capsules of amlodipine 10 mg taken once daily with water in the morning
|
|---|---|---|---|
|
Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group
|
87 Participants
|
99 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
Adverse Events
Aliskiren 300mg/ Amlodipine 10mg
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Aliskiren 150mg/ Amlodipine 10mg
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Amlodipine 10mg
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren 300mg/ Amlodipine 10mg
n=279 participants at risk
Aliskiren 300mg/ Amlodipine 10mg
|
Aliskiren 150mg/ Amlodipine 10mg
n=283 participants at risk
Aliskiren 150mg/ Amlodipine 10mg
|
Amlodipine 10mg
n=281 participants at risk
Amlodipine 10mg
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
0.36%
1/279
|
0.00%
0/283
|
0.00%
0/281
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/279
|
0.35%
1/283
|
0.00%
0/281
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.36%
1/279
|
0.00%
0/283
|
0.00%
0/281
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.36%
1/279
|
0.00%
0/283
|
0.00%
0/281
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.36%
1/279
|
0.00%
0/283
|
0.00%
0/281
|
Other adverse events
| Measure |
Aliskiren 300mg/ Amlodipine 10mg
n=279 participants at risk
Aliskiren 300mg/ Amlodipine 10mg
|
Aliskiren 150mg/ Amlodipine 10mg
n=283 participants at risk
Aliskiren 150mg/ Amlodipine 10mg
|
Amlodipine 10mg
n=281 participants at risk
Amlodipine 10mg
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
5.4%
15/279
|
8.1%
23/283
|
8.9%
25/281
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
16/279
|
5.3%
15/283
|
5.3%
15/281
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER