CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 932 enrolled
Drug / intervention
Valsartan/amlodipine 160/5 mg +2 moredrug
Likely dose
Valsartan/amlodipine 160/5 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/NCT01001572
NCT01001572Phase 3Completed
CompareCT.gov

A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy

Novartis·interventional·Posted Oct 26, 2009·Updated May 24, 2011

In Brief

A Phase 3 clinical trial evaluating Valsartan/amlodipine 160/5 mg, Valsartan 160 mg, and 1 other intervention for Essential Hypertension. Completed, enrolled 932 participants across 2 sites.

Detailed Summary

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Hypertension
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 26, 2009
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.7 years ago

Interventions

Valsartan/amlodipine 160/5 mgdrug

Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.

Valsartan 160 mgdrug

Valsartan 160 mg capsule taken orally once daily.

Placebodrug

1 capsule or tablet taken orally once daily