CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 488 enrolled
Drug / intervention
valsartan, amlodipine, HCTZ +1 moredrug
Likely dose
valsartan, amlodipine, HCTZ 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/NCT00931710
NCT00931710Phase 4Completed
CompareCT.gov

A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension

Novartis·interventional·Posted Jul 2, 2009·Updated Mar 7, 2011

In Brief

A Phase 4 clinical trial evaluating valsartan, amlodipine, HCTZ and Losartan, HCTZ followed by valsartan, amlodipine, HCTZ for Stage 2 Systolic Hypertension. Completed, enrolled 488 participants across 1 site.

Detailed Summary

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage 2 Systolic Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2009
Enrollment StartJul 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17 years ago

Interventions

valsartan, amlodipine, HCTZdrug

combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study

Losartan, HCTZ followed by valsartan, amlodipine, HCTZdrug

losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study