Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00263003
First received: December 6, 2005
Last updated: December 6, 2007
Last verified: December 2007
  Purpose

Study Objectives :

  • To demonstrate the reduction in office Blood Pressure following a 8-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference.
  • To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference.
  • To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan.
  • To compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
  • To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily

Condition Intervention Phase
Hypertension
Drug: Irbesartan/hydrochlorothiazide
Drug: Irbesartan
Phase 3

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 Randomized, Open Label Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Compare the reduction in office BP following a 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan

Secondary Outcome Measures:
  • Compare the reduction in office BP following a 4-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
  • Compare the response rate (defined as office SBP/DBP reduce more than 10mmHg from week 0) of patients after 4-week and 8-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
  • Compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
  • Ascertain the safety and tolerability of irbesartan/hydrochlorothiazide versus irbesartan when administered once daily.

Estimated Enrollment: 40
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mild to moderate hypertension with office Diastolic Blood Pressure (DBP) 90-109 mmHg and/or Systolic Blood Pressure (SBP) 140-179 mmHg
  • All women of child-bearing potential must have negative urine pregnancy tests within a week prior to initiation of therapy

Exclusion Criteria:

  • females who are pregnant or breast feeding
  • office DBP ≥ 110 mmHg or office SBP ≥ 180 mmHg
  • history of significant cardiovascular diseases which includes:

    • acute myocardial infarction within six months or any ischemic heart disease requiring medication.
    • cerebrovascular disease
  • history of significant renal diseases including:

    • serum creatinine > 3.0 mg/dl.
    • creatinine clearance < 30 ml/min.
  • severe biliary cirrhosis and cholestasis
  • refractory hypokalemia, hypercalcemia
  • history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
  • hepatic disease as indicated by any of the following:

    • SGOT or SGPT >3 x upper limit of normal.
    • Serum bilirubin > 2 x upper limit of normal.
  • any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objectives.
  • any other investigational drug given within 30 days of initiation of therapy, and participation in other clinical studies while enrolled in this protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263003

Locations
Taiwan
Sanofi-Aventis
Taipei, Taiwan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Sharon CHANG, MD Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00263003     History of Changes
Other Study ID Numbers: PM_L_0094
Study First Received: December 6, 2005
Last Updated: December 6, 2007
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
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 July 29, 2014