At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 443 enrolled
Drug / intervention
Aliskiren/Amlodipine +1 moredrug
Likely dose
Aliskiren/Amlodipine 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 Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African American Patients With Stage 2 Hypertension
In Brief
A Phase 4 clinical trial evaluating Aliskiren/Amlodipine and Amlodipine for Hypertension. Completed, enrolled 443 participants across 9 sites.
Detailed Summary
The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedMar 2009
Primary CompletionAug 2009
TodayJul 2026
First PostedMar 2, 2009
Enrollment StartFeb 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.3 years ago
Interventions
Aliskiren/Amlodipinedrug
Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipinedrug
Amlodipine 5 mg titrated to 10mg