At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 564 enrolled
Drug / intervention
Aliskiren +2 moredrug
Likely dose
Aliskiren 300 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 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension
In Brief
A Phase 3 clinical trial evaluating Aliskiren, Amlodipine, and 1 other intervention for Essential Hypertension. Completed, enrolled 564 participants across 8 sites in 8 countries.
Detailed Summary
This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Hypertension
CountriesBelgium, Egypt, Germany, Poland, Slovakia, Spain, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartJun 2008
Primary CompletionOct 2009
TodayJul 2026
First PostedApr 28, 2008
Enrollment StartJun 5, 2008
Primary CompletionOct 5, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.2 years ago
Interventions
Aliskirendrug
300 mg tablet
Amlodipinedrug
5 mg tablet
Hydrochlorothiazidedrug
12.5 mg and 25 mg capsule