NCT00263003

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
Last Updated

December 7, 2007

Status Verified

December 1, 2007

First QC Date

December 6, 2005

Last Update Submit

December 6, 2007

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • 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.

Interventions

Irbesartan/hydrochlorothiazideDRUG
IrbesartanDRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

IrbesartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sharon CHANG, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

June 1, 2005

Last Updated

December 7, 2007

Record last verified: 2007-12

Locations

TW(1)