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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

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

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

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


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

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


Inclusion Criteria:

- Established essential hypertension, untreated or treated but uncontrolled with


- Office SBP ≥ 160 mmHg for untreated patients

- Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive


- 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.

Locations and Contacts

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, Seoul, Korea, Republic of

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, Taipei, Taiwan

Sanofi-Aventis Administrative Office, Bangkok, Thailand

Sanofi-Aventis Administrative Office, Megrine, Tunisia

Sanofi-Aventis Administrative Office, Ho Chi Minh City, Vietnam

Additional Information

Starting date: July 2007
Last updated: July 16, 2010

Page last updated: August 23, 2015

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