Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00263003
  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 III

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Irbesartan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Open Label Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension

Further study details as provided by Sanofi-Aventis:

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

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

Related Info  This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:
Irbesartan
Vascular Diseases
Angiotensin II
Hydrochlorothiazide
Hypertension

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

ClinicalTrials.gov processed this record on January 16, 2009