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Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension (COSIMA2)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00500604
First received: July 11, 2007
Last updated: July 16, 2010
Last verified: July 2010
History of Changes
  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 4

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

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]

Enrollment: 1617
Study Start Date: July 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: Irbesartan/hydrochlorothiazide
150/12.5mg tablet and 300/12.5mg tablet
Drug: Hydrochlorothiazide
12.5 mg administered orally, once daily in the morning
Active Comparator: 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.
 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
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
Investigators
Study Director: Benedict Blayney Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00500604     History of Changes
Other Study ID Numbers: IRBEH_R_02584
Study First Received: July 11, 2007
Last Updated: July 16, 2010
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Irbesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013