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

Hypertension Clinical Trial

— COSIMA2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500604
• Other study ID #: IRBEH_R_02584
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2007
• Last updated: July 16, 2010
• Start date: July 2007
• Est. completion date: January 2010

Study information

• Verified date: July 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1617
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Irbesartan/hydrochlorothiazide
150/12.5mg tablet and 300/12.5mg tablet
• Valsartan/hydrochlorothiazide
80/12.5mg tablet and 160/12.5mg tablet
• Hydrochlorothiazide
12.5 mg administered orally, once daily in the morning

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Egypt,  Hong Kong,  India,  Indonesia,  Korea, Republic of,  Malaysia,  Morocco,  Pakistan,  Philippines,  Singapore,  Taiwan,  Thailand,  Tunisia,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in mean SBP as measured by HBPM		From week 0 to week 24	No
Secondary	Reduction in mean DBP as measured by HBPM		From week 0 to weeks 16 and 24	No
Secondary	Reduction in mean morning and evening SBP as measured by HBPM		From week 0 to weeks 16 and 24	No
Secondary	Reduction in mean morning and evening DBP as measured by HBPM		From week 0 to weeks 16 and 24	No
Secondary	Reduction in mean SBP and mean DBP evaluated at the doctor's office		From week 0 to weeks 16 and 24	No
Secondary	Number of normalised patients as measured by HBPM		From week 0 to weeks 16 and 24	No
Secondary	Number of normalised patients evaluated at the doctor's office		From week 0 to weeks 16 and 24	No
Secondary	Reduction in mean SBP as measured by HBPM		From week 0 to week 16	No
Secondary	Adverse events, vital signs, laboratory tests		From visit 1 to end of study	Yes