search
Back to results

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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Irbesartan/hydrochlorothiazide
Irbesartan
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Outcomes

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.

Full Information

First Posted
December 6, 2005
Last Updated
December 6, 2007
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00263003
Brief Title
Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Official Title
A Randomized, Open Label Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Irbesartan/hydrochlorothiazide
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Primary Outcome Measure Information:
Title
Compare the reduction in office BP following a 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
Secondary Outcome Measure Information:
Title
Compare the reduction in office BP following a 4-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
Title
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
Title
Compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
Title
Ascertain the safety and tolerability of irbesartan/hydrochlorothiazide versus irbesartan when administered once daily.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon CHANG, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs