At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 774 enrolled
Drug / intervention
Aliskiren +3 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 54 Week, Randomized, Double-blind, Parallel-group, Multicenter Study Evaluating the Long-term Gastrointestinal (GI) Safety and Tolerability of Aliskiren (300 mg) Compared to Ramipril (10 mg) in Patients With Essential Hypertension
In Brief
A Phase 4 clinical trial evaluating Aliskiren, Ramipril, and 2 other interventions for Hypertension. Completed, enrolled 774 participants across 7 sites in 7 countries.
Detailed Summary
This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesArgentina, Colombia, France, Germany, India, Spain, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedMar 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedMar 10, 2008
Enrollment StartFeb 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.3 years ago
Interventions
Aliskirendrug
Aliskiren 300 mg once a day
Ramiprildrug
Ramipril 10 mg once a day
Placebo to Ramiprilother
Placebo capsules to match ramipril.
Placebo to Aliskirenother
Placebo tablets to match aliskiren.