Trial Outcomes & Findings for Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus (NCT NCT00787605)
NCT ID: NCT00787605
Last Updated: 2016-10-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
860 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2016-10-27
Participant Flow
Participant milestones
| Measure |
Aliskiren/HCTZ
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
428
|
432
|
|
Overall Study
COMPLETED
|
382
|
376
|
|
Overall Study
NOT COMPLETED
|
46
|
56
|
Reasons for withdrawal
| Measure |
Aliskiren/HCTZ
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Overall Study
Administrative Problems
|
3
|
0
|
|
Overall Study
Adverse Event
|
14
|
25
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Protocol Violation
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
13
|
|
Overall Study
Lack of Efficacy
|
13
|
9
|
Baseline Characteristics
Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Aliskiren/HCTZ
n=428 Participants
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=432 Participants
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
Total
n=860 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 10.01 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
216 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
439 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set, intent-to-treat
Outcome measures
| Measure |
Aliskiren/HCTZ
n=426 Participants
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=429 Participants
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
|
-28.82 mmHg
Standard Error 0.722
|
-26.22 mmHg
Standard Error 0.719
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set, intent-to-treat
Outcome measures
| Measure |
Aliskiren/HCTZ
n=426 Participants
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=429 Participants
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
|
-9.92 mmHg
Standard Error 0.414
|
-8.97 mmHg
Standard Error 0.412
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set, intent-to-treat
Response defined by mean sitting Systolic Blood Pressure \< 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure \>= 20 mm Hg from baseline
Outcome measures
| Measure |
Aliskiren/HCTZ
n=426 Participants
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=429 Participants
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Percentage of Responders
|
74.2 Percentage of Participants
|
68.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: after 8 weeks of treatmentPopulation: Full analysis set, intent-to-treat
Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure \< 130/80 mmHg.
Outcome measures
| Measure |
Aliskiren/HCTZ
n=426 Participants
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=429 Participants
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Percentage of Patients Achieving Blood Pressure Control
|
23.2 Percentage of Participants
|
13.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set, intent-to-treat
Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)
Outcome measures
| Measure |
Aliskiren/HCTZ
n=428 Participants
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=432 Participants
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Biomarker Measurements
Plasma Renin activity (ng/ml/h) (N= 317, 300)
|
0.42 ratio
95% Confidence Interval 2.41 • Interval 0.37 to 0.48
|
1.75 ratio
95% Confidence Interval 2.10 • Interval 1.57 to 1.94
|
|
Biomarker Measurements
Plasma Renin concentration (ng/L) (N=315, 299)
|
9.53 ratio
95% Confidence Interval 189.75 • Interval 8.32 to 10.91
|
1.49 ratio
95% Confidence Interval 21.59 • Interval 1.36 to 1.62
|
|
Biomarker Measurements
Cystatin C (mg/L) (N = 327 , 310)
|
1.04 ratio
95% Confidence Interval 0.15 • Interval 1.03 to 1.06
|
0.98 ratio
95% Confidence Interval 0.09 • Interval 0.97 to 0.99
|
SECONDARY outcome
Timeframe: after 8 weeks of treatmentPopulation: safety
Percentage of patients with Adverse Event and percentage of patients with edema
Outcome measures
| Measure |
Aliskiren/HCTZ
n=428 Participants
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=431 Participants
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Evaluate the Safety and Tolerability
Any Adverse Event
|
36.0 Percentage of participants
|
48.3 Percentage of participants
|
|
Evaluate the Safety and Tolerability
edema
|
2.6 Percentage of participants
|
17.6 Percentage of participants
|
Adverse Events
Aliskiren/HCTZ
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
Amlodipine
Serious events: 4 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren/HCTZ
n=428 participants at risk
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=431 participants at risk
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/428
|
0.23%
1/431
|
|
Cardiac disorders
Angina unstable
|
0.23%
1/428
|
0.00%
0/431
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/428
|
0.23%
1/431
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/428
|
0.23%
1/431
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.23%
1/428
|
0.00%
0/431
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/428
|
0.46%
2/431
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/428
|
0.00%
0/431
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/428
|
0.23%
1/431
|
|
Vascular disorders
Hypertension
|
0.00%
0/428
|
0.23%
1/431
|
Other adverse events
| Measure |
Aliskiren/HCTZ
n=428 participants at risk
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
|
Amlodipine
n=431 participants at risk
Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
|
|---|---|---|
|
General disorders
Oedema peripheral
|
2.1%
9/428
|
16.2%
70/431
|
|
Nervous system disorders
Headache
|
4.4%
19/428
|
5.1%
22/431
|
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; or the publication of the trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER