CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 384 enrolled
Drug / intervention
Valsartan + HCTZ +2 moredrug
Likely dose
Valsartan + HCTZ 12.5 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/NCT00698646
NCT00698646Phase 4Completed
CompareCT.gov

A 16 Week Multi-center, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Valsartan/Hydrochlorothiazide (HCTZ) Combination Therapy Compared to Patients Initiated With Valsartan Monotherapy or Hydrochlorothiazide (HCTZ) Monotherapy in Very Elderly Patients With Essential Hypertension

Novartis Pharmaceuticals·interventional·Posted Jun 17, 2008·Updated Apr 19, 2011

In Brief

A Phase 4 clinical trial evaluating Valsartan + HCTZ, Valsartan, and 1 other intervention for Hypertension. Completed, enrolled 384 participants across 20 sites.

Detailed Summary

The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 17, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.0 years ago

Interventions

Valsartan + HCTZdrug

At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.

Valsartandrug

At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.

HCTZdrug

At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.