CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 412 enrolled
Drug / intervention
HCTZ + Amlodipine +1 moredrug
Likely dose
Valsartan 160–320 mg with HCTZ 12.5–25 mg daily (force-titration); or HCTZ 12.5–25 mg with amlodipine 5–10 mg dailyAI-extracted
Key inclusion· 3
  • ✓Age 40 years or older
  • ✓Moderate or severe hypertension with systolic BP ≥150 mmHg and diastolic BP <110 mmHg
  • ✓Central (abdominal) obesity
Key exclusion· 9
  • ✕Systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg
  • ✕Currently taking more than 3 antihypertensive medications
  • ✕Unable to discontinue all current blood pressure medications for up to 4 weeks
  • ✕History of Type 1 or Type 2 diabetes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00439738
NCT00439738Phase 4Completed
CompareCT.gov

A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients

Novartis Pharmaceuticals·interventional·Posted Feb 26, 2007·Updated May 16, 2017

In Brief

A Phase 4 clinical trial evaluating HCTZ + Amlodipine and Valsartan/HCTZ for Hypertension. Completed, enrolled 412 participants across 5 sites.

Detailed Summary

The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure \[MSSBP\] \>150 mmHg) patients.

Study Details

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

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2007
Enrollment StartDec 1, 2006
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.3 years ago

Interventions

HCTZ + Amlodipinedrug

* 12.5 mg HCTZ capsules * 25 mg HCTZ capsules * 5 mg amlodipine capsules * 10 mg amlodipine capsules

Valsartan/HCTZdrug

* 160 mg film-coated valsartan tablets * 320 mg film-coated valsartan tablets * 12.5 mg HCTZ capsules * 25 mg HCTZ capsules