A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan.
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|ClinicalTrials.gov Identifier: NCT00250562|
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : August 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: valsartan plus hydrochlorothiazide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1171 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Double-blind, Randomized, Active Controlled, Parallel Group Trial Comparing the Combinations of Valsartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Valsartan 80 mg in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80mg|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
- Change from baseline diastolic blood pressure after 8 weeks
- Change from baseline systolic blood pressure after 8 weeks
- Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250562
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936|
|Study Director:||Novartis Pharmaceutical||Novartis Pharmaceuticals|