At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,254 enrolled
Drug / intervention
Amlodipine +2 moredrug
Likely dose
Amlodipine 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.
A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension
In Brief
A Phase 3 clinical trial evaluating Amlodipine, hydrochlorothiazide, and 1 other intervention for Hypertension. Completed, enrolled 1,254 participants across 10 sites in 10 countries.
Detailed Summary
This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesCanada, Costa Rica, France, Germany, Greece, Guatemala, South Africa, Switzerland, United Kingdom, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedNov 2008
Primary CompletionNov 2010
TodayJul 2026
First PostedNov 25, 2008
Enrollment StartNov 1, 2008
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.6 years ago
Interventions
Amlodipinedrug
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
hydrochlorothiazidedrug
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Aliskirendrug
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.