Phase 3
N=1,191
Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00765674 ↗Enrolled (actual)
1,191
Serious AEs
1.1%
Results posted
May 2011
Primary outcome: Primary: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) — -31.37; -27.99; -30.77; -37.92 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aliskiren (Drug); Amlodipine (Drug); Hydrochlorothiazide (HCTZ) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) |
-31.37; -27.99; -30.77; -37.92 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) |
-18.03; -14.32; -17.03; -20.63 | — |
| SECONDARY Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8) |
41.3; 33.1; 39.0; 62.3 | — |
| SECONDARY Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8) |
-20.30; -16.27; -18.67; -25.29; -13.29; -9.57 | — |
Summary
This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.
Eligibility Criteria
Inclusion Criteria
- Male or female
- 18 years of age or older
- msDBP and msSBP requirements:
- 3A:
- Diagnosis of moderate to severe hypertension (msSBP ≥ 160 mmHg and < 200 mmHg, and/or msDBP ≥ 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6 (Qualifying BP visit)
- In addition, at the visit immediately prior to the above qualifying visit, patients were also to have msSBP ≥ 145 mmHg and < 200 mmHg and msDBP ≥ 95 mmHg and < 120 mmHg) at Visits 3, 5 or 5.
- Patients had to meet the above two sets of requirements at subsequent adjacent visits, i.e. either Visits 3 and 4, Visits 4 and 5, or Visits 5 and 6.
- OR
- 3B:
- msSBP ≥ 180 mmHg and < 200 mmHg with msDBP ≥ 95 mmHg and < 120 mmHg, or msDBP ≥ 110 mmHg and < 120 mmHg with msSBP ≥ 150 mmHg and < 200 mmHg after at least one week of treatment with placebo (Visit 3 and on).
Exclusion Criteria
- Continued use of anti-hypertensive medicines or use of 4 or more hypertensive medicines at study start
- Patients with an msSBP ≥ 200 mmHg or msDBP ≥ 120 mmHg at any time during the placebo run-in period were to be discontinued from the study.
- Extremely elevated (defined) blood pressure at any point during the study
- Pregnant or lactating women
- Pre-menopausal women not taking accepted form of birth control
- History or evidence of secondary form of hypertension
- History of cardiovascular conditions
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00765674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.