Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg; Drug: Irbesartan 150mg

• Registration Number: NCT00847834
• Lead Sponsor: Sanofi

Brief Summary

To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2004-06
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 968

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Irbesartan 150mg / Hydrochlorothiazide 12.5mg	4 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by: * If DBP\<85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg * If DBP≥85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet of Irbesartan 150mg
1	Irbesartan 150mg	4 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by: * If DBP\<85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg * If DBP≥85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet of Irbesartan 150mg
2	Irbesartan 150mg / Hydrochlorothiazide 12.5mg	2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by 2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg followed by: * If DBP\<85mmHg: 4 weeks of of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg * If DBP≥85mmHg: 4 weeks of two tablets Irbesartan 150mg / Hydrochlorothiazide 12.5mg
2	Irbesartan 150mg	2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by 2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg followed by: * If DBP\<85mmHg: 4 weeks of of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg * If DBP≥85mmHg: 4 weeks of two tablets Irbesartan 150mg / Hydrochlorothiazide 12.5mg

Primary Outcome Measures

Name	Time	Method
Proportion of patients who reach a diastolic blood pressure <85 mmHg	At 2, 4 and 8 weeks

Trial Locations

Locations (1)

Sanofi aventis administrative office; 🇨🇳 Beijing, China