Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00500604

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Irbesartan/hydrochlorothiazide Drug: Valsartan/hydrochlorothiazide Drug: Hydrochlorothiazide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Valsartan Irbesartan

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Reduction in mean SBP as measured by HBPM [ Time Frame: From week 0 to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in mean DBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ] [ Designated as safety issue: No ]
Reduction in mean morning and evening SBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ] [ Designated as safety issue: No ]
Reduction in mean morning and evening DBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ] [ Designated as safety issue: No ]
Reduction in mean SBP and mean DBP evaluated at the doctor's office [ Time Frame: From week 0 to weeks 16 and 24 ] [ Designated as safety issue: No ]
Number of normalised patients as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ] [ Designated as safety issue: No ]
Number of normalised patients evaluated at the doctor's office [ Time Frame: From week 0 to weeks 16 and 24 ] [ Designated as safety issue: No ]
Reduction in mean SBP as measured by HBPM [ Time Frame: From week 0 to week 16 ] [ Designated as safety issue: No ]
Adverse events, vital signs, laboratory tests [ Time Frame: From visit 1 to end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1325
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.	Drug: Irbesartan/hydrochlorothiazide 150/12.5mg tablet and 300/12.5mg tablet Drug: Hydrochlorothiazide 12.5 mg administered orally, once daily in the morning
B: Active Comparator 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.	Drug: Valsartan/hydrochlorothiazide 80/12.5mg tablet and 160/12.5mg tablet Drug: Hydrochlorothiazide 12.5 mg administered orally, once daily in the morning

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500604

Locations

Egypt
Sanofi-aventis Administrative Office
Cairo, Egypt
Hong Kong
Sanofi-aventis Administrative Office
Hong Kong, Hong Kong
India
Sanofi-aventis Administrative Office
Mumbai, India
Indonesia
Sanofi-aventis Administrative Office
Jakarta, Indonesia
Korea, Republic of
Sanofi-aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-aventis Administrative Office
Kuala Lumpur, Malaysia
Morocco
Sanofi-aventis Administrative Office
Casablanca, Morocco
Pakistan
Sanofi-aventis Administrative Office
Karachi, Pakistan
Philippines
Sanofi-aventis Administrative Office
Makati City, Philippines
Singapore
Sanofi-aventis Administrative Office
Singapore, Singapore
Taiwan
Sanofi-aventis Administrative Office
Taipei, Taiwan
Sanofi-aventis Administrative Office
Taipei, Taiwan
Thailand
Sanofi-aventis Administrative Office
Bangkok, Thailand
Tunisia
Sanofi-aventis Administrative Office
Megrine, Tunisia
Vietnam
Sanofi-aventis Administrative Office
Ho Chi Minh City, Vietnam

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Benedict Blayney

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	IRBEH_R_02584
Study First Received:	July 11, 2007
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00500604 History of Changes
Health Authority:	Taiwan: Institutional Review Board

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Irbesartan
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009