CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 698 enrolled
Drug / intervention
Valsartan/amlodipine 80/5 mg +1 moredrug
Likely dose
Valsartan/amlodipine 80/5 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.

Search/NCT00413049
NCT00413049Phase 3Completed
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A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Amlodipine 5 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Monotherapy

Novartis·interventional·Posted Dec 19, 2006·Updated Apr 29, 2011

In Brief

A Phase 3 clinical trial evaluating Valsartan/amlodipine 80/5 mg and Amlodipine 5 mg for Hypertension. Completed, enrolled 698 participants across 12 sites.

Detailed Summary

This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2006
Enrollment StartJan 1, 2007
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.5 years ago

Interventions

Valsartan/amlodipine 80/5 mgdrug

1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

Amlodipine 5 mgdrug

1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.