At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 451 enrolled
Drug / intervention
Aliskiren +1 moredrug
Likely dose
Aliskiren 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Active-controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to HCTZ (25 mg) in Older Patients With Stage 2 Systolic Hypertension
In Brief
A Phase 4 clinical trial evaluating Aliskiren and Hydrochlorothiazide for Hypertension. Completed, enrolled 451 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionApr 2009
TodayJul 2026
First PostedSep 26, 2008
Enrollment StartSep 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.8 years ago
Interventions
Aliskirendrug
Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks
Hydrochlorothiazidedrug
Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks