At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,694 enrolled
Drug / intervention
Placebo +8 moredrug
Likely dose
Aliskiren 150 mg tabletfrom 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 Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Amlodipine in Patients With Essential Hypertension
In Brief
A Phase 3 clinical trial evaluating Placebo, Aliskiren 150 mg tablet, and 7 other interventions for Hypertension. Completed, enrolled 2,694 participants across 18 sites in 18 countries.
Detailed Summary
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesArgentina, Australia, Canada, Colombia, Denmark, Finland, Greece, Italy, Mexico, Panama, Peru, Romania, Russia, South Africa, Spain, Sweden, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartSep 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedAug 22, 2008
Enrollment StartSep 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.9 years ago
Interventions
Placebodrug
Aliskiren 150 mg tabletdrug
Aliskiren 300 mg tabletdrug
Amlodipine 5 mg capsuledrug
Amlodipine 10 mg capsuledrug
Aliskiren/amlodipine 150/5 mg tabletdrug
Aliskiren/amlodipine 150/10 mg tabletdrug
Aliskiren/amlodipine 300/5 mg tabletdrug
Aliskiren/amlodipine 300/10 mg tabletdrug