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Completed

NCT Number: NCT00500604

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office, Cairo, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irbesartan/hydrochlorothiazide

Drug

150/12.5mg tablet and 300/12.5mg tablet

Valsartan/hydrochlorothiazide

Drug

80/12.5mg tablet and 160/12.5mg tablet

Hydrochlorothiazide

Drug

12.5 mg administered orally, once daily in the morning

Primary outcomes

  1. Reduction in mean SBP as measured by HBPM

    Time frame: From week 0 to week 24

Secondary outcomes

  1. Reduction in mean DBP as measured by HBPM

    Time frame: From week 0 to weeks 16 and 24

  2. Reduction in mean morning and evening SBP as measured by HBPM

    Time frame: From week 0 to weeks 16 and 24

  3. Reduction in mean morning and evening DBP as measured by HBPM

    Time frame: From week 0 to weeks 16 and 24

  4. Reduction in mean SBP and mean DBP evaluated at the doctor's office

    Time frame: From week 0 to weeks 16 and 24

  5. Number of normalised patients as measured by HBPM

    Time frame: From week 0 to weeks 16 and 24

  6. Number of normalised patients evaluated at the doctor's office

    Time frame: From week 0 to weeks 16 and 24

  7. Reduction in mean SBP as measured by HBPM

    Time frame: From week 0 to week 16

  8. Adverse events, vital signs, laboratory tests

    Time frame: From visit 1 to end of study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: COSIMA2

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 12, 2007
Registry last updated
Jul 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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