drugset / Trial / NCT00250562

A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan.

NCT00250562 ↗

Phase 3 Completed 1171 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries worldwide for the treatment of hypertension. In China the usual recommended starting and maintenance dose is 80 mg o.d. The combination of HCTZ 12.5 mg with valsartan 80 mg has been shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected patients6. This fixed combination is registered in most countries worldwide. The potential benefits of these combinations should be evaluated in patients not adequately controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and tolerability of adding HCTZ 12.5 mg to valsartan 80 mg in those hypertensive patients. This study is not recruiting in the US.

Timeline

Start
2005-10
Primary completion
2006-06
Completion
2006-06

Outcome

Met primary endpoint

paper There were significantly greater reductions in MSDBP (8.4 mmHg vs. 6.2 mmHg) PMID 18761785 ↗

paper in the VAL80/HCTZ12.5 group as compared with the VAL80 group at endpoint (p < 0.001). PMID 18761785 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrochlorothiazide Unknown 12.5 mg —
Background Valsartan Unknown 80 mg Oral

Indications