CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,134 enrolled
Drug / intervention
Valsartan/amlodipine 80/5 mg +2 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/NCT00413413
NCT00413413Phase 3Completed
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A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80 mg Monotherapy.

Novartis Pharmaceuticals·interventional·Posted Dec 19, 2006·Updated Apr 28, 2011

In Brief

A Phase 3 clinical trial evaluating Valsartan/amlodipine 80/5 mg, Valsartan 80 mg, and 1 other intervention for Hypertension. Completed, enrolled 1,134 participants across 19 sites.

Detailed Summary

This study evaluated 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, 1 placebo capsule to match valsartan once daily

Valsartan 80 mgdrug

1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Valsartan 160 mgdrug

1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily