Phase 4
N=451
Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00760266 ↗Enrolled (actual)
451
Serious AEs
1.6%
Results posted
Jan 2011
Primary outcome: Primary: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4 — -29.6; -22.3 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aliskiren (Drug); Hydrochlorothiazide (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4 |
-29.6; -22.3 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4 |
-11.1; -9.2 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8 |
-33.2; -25.7; -13.3; -10.1 | — |
| SECONDARY Percentage of Responders at Week 4 and Week 8 |
73.3; 55.9; 83.1; 67.6 | — |
| SECONDARY Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8 |
49.8; 33.3; 62.2; 39.2 | — |
Summary
The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients, ≥ 55 years old
- Patients with essential hypertension
- Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 160 mm Hg and 5 mIU/mL)
- Use of other investigational drugs within 30 days of enrollment.
Other exclusions may apply.
Data sourced from ClinicalTrials.gov (NCT00760266). 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.