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

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ClinicalTrials.gov Identifier: NCT00500604
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : July 19, 2010
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE July 11, 2007
First Posted Date  ICMJE July 12, 2007
Last Update Posted Date July 19, 2010
Study Start Date  ICMJE July 2007
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2007)
Reduction in mean SBP as measured by HBPM [ Time Frame: From week 0 to week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00500604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2007)
  • Reduction in mean DBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Reduction in mean morning and evening SBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Reduction in mean morning and evening DBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Reduction in mean SBP and mean DBP evaluated at the doctor's office [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Number of normalised patients as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Number of normalised patients evaluated at the doctor's office [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Reduction in mean SBP as measured by HBPM [ Time Frame: From week 0 to week 16 ]
  • Adverse events, vital signs, laboratory tests [ Time Frame: From visit 1 to end of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2007)
  • Reduction in mean DBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Reduction in mean morning and evening SBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Reduction in mean morning and evening DBP as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Reduction in mean SBP and mean DBP evaluated at the doctor's office [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Number of normalised patients as measured by HBPM [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Number of normalised patients evaluated at the doctor's office [ Time Frame: From week 0 to weeks 16 and 24 ]
  • Reduction in mean SBP as measured by HBPM [ Time Frame: From week 0 to week 16 ]
  • Adverse events, vital signs, laboratory tests
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Irbesartan/hydrochlorothiazide
    150/12.5mg tablet and 300/12.5mg tablet
  • Drug: Valsartan/hydrochlorothiazide
    80/12.5mg tablet and 160/12.5mg tablet
  • Drug: Hydrochlorothiazide
    12.5 mg administered orally, once daily in the morning
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Irbesartan/hydrochlorothiazide
    • Drug: Hydrochlorothiazide
  • 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.
    Interventions:
    • Drug: Valsartan/hydrochlorothiazide
    • Drug: Hydrochlorothiazide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2010)
1617
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2007)
1040
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt,   Hong Kong,   India,   Indonesia,   Korea, Republic of,   Malaysia,   Morocco,   Pakistan,   Philippines,   Singapore,   Taiwan,   Thailand,   Tunisia,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00500604
Other Study ID Numbers  ICMJE IRBEH_R_02584
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Benedict Blayney Sanofi
PRS Account Sanofi
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP