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

Condition(s) targeted: Hypertension

Intervention: Irbesartan/hydrochlorothiazide (Drug); Valsartan/hydrochlorothiazide (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Benedict Blayney, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com

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

Official title: A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Reduction in mean SBP as measured by HBPM

Secondary outcome:

Reduction in mean DBP as measured by HBPM

Reduction in mean morning and evening SBP as measured by HBPM

Reduction in mean morning and evening DBP as measured by HBPM

Reduction in mean SBP and mean DBP evaluated at the doctor's office

Number of normalised patients as measured by HBPM

Number of normalised patients evaluated at the doctor's office

Reduction in mean SBP as measured by HBPM

Adverse events, vital signs, laboratory tests

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com

Sanofi-Aventis, Cairo, Egypt; Recruiting

Sanofi-Aventis, Hong Kong, Hong Kong; Recruiting

Sanofi-Aventis, Mumbai, India; Recruiting

Sanofi-Aventis, Jakarta, Indonesia; Recruiting

Sanofi-Aventis, Seoul, Korea, Republic of; Recruiting

Sanofi-Aventis, Kuala Lumpur, Malaysia; Recruiting

Sanofi-Aventis, Casablanca, Morocco; Not yet recruiting

Sanofi-Aventis, Karachi, Pakistan; Recruiting

Sanofi-Aventis, Manila, Philippines; Recruiting

Sanofi-Aventis, Singapore, Singapore; Recruiting

Sanofi-Aventis, Taipei, Taiwan; Recruiting

Sanofi-Aventis, Bangkok, Thailand; Recruiting

Sanofi-Aventis, Megrine, Tunisia; Recruiting

Sanofi-Aventis, Ho Chi Minh City, Vietnam; Recruiting

Starting date: July 2007
Last updated: October 2, 2008