At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 332 enrolled
Drug / intervention
Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks +1 moredrug
Likely dose
Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks 12.5 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 Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ Versus Amlodipine in African American Patients With Stage 2 Hypertension
In Brief
A Phase 4 clinical trial evaluating Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks and Amlodipine: 8 weeks for Hypertension. Completed, enrolled 332 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedAug 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedAug 22, 2008
Enrollment StartJul 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.9 years ago
Interventions
Aliskiren Hydrochlorothiazide (HCTZ): 8 weeksdrug
Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
Amlodipine: 8 weeksdrug
Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks