CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 818 enrolled
Drug / intervention
Aliskiren 300 mg +4 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.

Search/NCT00777946
NCT00777946Phase 3Completed
CompareCT.gov

A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy

Novartis·interventional·Posted Oct 22, 2008·Updated Jul 12, 2011

In Brief

A Phase 3 clinical trial evaluating Aliskiren 300 mg, Aliskiren/Amlodipine 300/5 mg, and 3 other interventions for Hypertension. Completed, enrolled 818 participants across 9 sites in 9 countries.

Detailed Summary

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesEstonia, France, Iceland, India, Italy, Lithuania, South Korea, Spain, Venezuela
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2008
Enrollment StartOct 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.7 years ago

Interventions

Aliskiren 300 mgdrug

Aliskiren 300 mg tablet taken orally once a day with a glass of water.

Aliskiren/Amlodipine 300/5 mgdrug

Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.

Aliskiren/Amlodipine 300/10 mgdrug

Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.

Placebo to Aliskirendrug

Placebo to Aliskiren tablet taken orally once a day.

Placebo to Aliskiren/Amlodipinedrug

Placebo to Aliskiren/Amlodipine taken orally once a day.