CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,474 enrolled
Drug / intervention
Valsartan + amlodipine 40/2.5 mg +8 moredrug
Likely dose
Valsartan + amlodipine 40/2.5 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/NCT00425373
NCT00425373Phase 3Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive Patients

Novartis Pharmaceuticals·interventional·Posted Jan 23, 2007·Updated Apr 29, 2011

In Brief

A Phase 3 clinical trial evaluating Valsartan + amlodipine 40/2.5 mg, Valsartan + amlodipine 40/5 mg, and 7 other interventions for Essential Hypertension. Completed, enrolled 1,474 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 23, 2007
Enrollment StartNov 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.4 years ago

Interventions

Valsartan + amlodipine 40/2.5 mgdrug

Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan + amlodipine 40/5 mgdrug

Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan + amlodipine 80/2.5 mgdrug

Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan + amlodipine 80/5 mgdrug

Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan 40 mgdrug

Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan 80 mgdrug

Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Amlodipine 2.5 mgdrug

Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily

Amlodipine 5 mgdrug

Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily

Placebodrug

4 tablet and 2 capsule placebos taken once daily