Phase 4
N=386
Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00772577 ↗Enrolled (actual)
386
Serious AEs
1.6%
Results posted
Mar 2011
Primary outcome: Primary: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) — 167.0; 168.2; 138.9; 151.6 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aliskiren Hydrochlorothiazide (Drug); Ramipril (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) |
167.0; 168.2; 138.9; 151.6; -28.1; -16.6 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) |
94.3; 96.3; 84.2; 92.7; -10.1; -3.6 | — |
| SECONDARY Percentage of Patients Achieving Blood Pressure Control During 8 Weeks |
63.7; 30.0 | — |
| SECONDARY Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP) |
87.9; 63.2 | — |
| SECONDARY Change From Baseline in Mean Sitting Pulse Pressure (MSPP) |
72.7; 71.9; 54.7; 58.9; -18.0; -13.0 | — |
Summary
Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension
Eligibility Criteria
Inclusion Criteria
- Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Male or female outpatients, 18 years of age and older.
- Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and 450 msec for males and > 470 msec for females at screening.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00772577). 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.