Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension

NCT ID: NCT00500604

Last Updated: 2010-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1617 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-01-31

Brief Summary

The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.

The secondary objectives are:

• To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24
• To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
• To compare the difference in mean SBP evaluated by HBPM at week 16
• To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24
• To determine the incidence and severity of adverse events

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

• period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks
• period 2: One 150/12.5mg tablet every morning for 8 weeks.
• period 3: One 300/12.5mg tablet every morning for 8 weeks.
• period 4: Two 150/12.5mg tablets every morning for 8 weeks.

Group Type: EXPERIMENTAL

Irbesartan/hydrochlorothiazide

Intervention Type: DRUG

150/12.5mg tablet and 300/12.5mg tablet

Hydrochlorothiazide

Intervention Type: DRUG

12.5 mg administered orally, once daily in the morning

B

• period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks
• period 2: One 80/12.5mg tablet every morning for 8 weeks.
• period 3: One 160/12.5mg tablet every morning for 8 weeks.
• period 4: Two 80/12.5mg tablets every morning for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Valsartan/hydrochlorothiazide

Intervention Type: DRUG

80/12.5mg tablet and 160/12.5mg tablet

Hydrochlorothiazide

Intervention Type: DRUG

12.5 mg administered orally, once daily in the morning

Interventions

Irbesartan/hydrochlorothiazide

150/12.5mg tablet and 300/12.5mg tablet

Intervention Type: DRUG

Valsartan/hydrochlorothiazide

80/12.5mg tablet and 160/12.5mg tablet

Intervention Type: DRUG

Hydrochlorothiazide

12.5 mg administered orally, once daily in the morning

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Established essential hypertension, untreated or treated but uncontrolled with treatment:

• Office SBP ≥ 160 mmHg for untreated patients
• Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive drug.
• Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:

• ACE inhibitor / calcium channel blocker
• Beta blocker / calcium channel blocker
• Beta blocker / low dose diuretic
• ACE inhibitor / low dose diuretic

Exclusion Criteria

• SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1
• Known or suspected causes of secondary hypertension
• Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
• Type 1 diabetes mellitus
• Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject
• Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
• Known contraindications to any of the study drugs
• Concomitant use of any other antihypertensive treatment
• Use of any of the investigational products for this study within the 3 months prior to the study
• Inability to obtain a valid HBPM recording i.e., obesity, arm circumference > 32 cm or arrhythmia
• Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
• Pregnant or breast-feeding women
• Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Benedict Blayney

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Cairo, , Egypt

Sanofi-Aventis Administrative Office

Hong Kong, , Hong Kong

Sanofi-Aventis Administrative Office

Mumbai, , India

Sanofi-Aventis Administrative Office

Jakarta, , Indonesia

Sanofi-Aventis Administrative Office

Kuala Lumpur, , Malaysia

Sanofi-Aventis Administrative Office

Casablanca, , Morocco

Sanofi-Aventis Administrative Office

Karachi, , Pakistan

Sanofi-Aventis Administrative Office

Makati City, , Philippines

Sanofi-Aventis Administrative Office

Singapore, , Singapore

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Sanofi-Aventis Administrative Office

Bangkok, , Thailand

Sanofi-Aventis Administrative Office

Mégrine, , Tunisia

Sanofi-Aventis Administrative Office

Ho Chi Minh City, , Vietnam

Countries

Egypt; Hong Kong; India; Indonesia; Malaysia; Morocco; Pakistan; Philippines; Singapore; South Korea; Taiwan; Thailand; Tunisia; Vietnam

Other Identifiers

IRBEH_R_02584

Identifier Type: -

Identifier Source: org_study_id