NCT00264212

Brief Summary

To compare the antihypertensive efficacy and tolerability of irbesartan and irbesartan-hydrochlorothiazide fixed combination therapy with amlodipine and amlodipine plus hydrochlorothiazide in the treatment of isolated systolic hypertension.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
436

participants targeted

Target at P75+ for phase_4 hypertension

Geographic Reach
8 countries

8 active sites

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

August 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

December 9, 2005

Last Update Submit

December 17, 2007

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in office seated SBP at week 12

Secondary Outcomes (1)

  • At 4, 8 and 12 weeks: Number of responders and normalized, Change from baseline in pulse pressure (SBP-DBP), Change from baseline in standing SBP, Safety : Change in standing SBP/DBP, incidence of orthostatic hypotension, adverse events

Interventions

irbesartan and irbesartan-hydrochlorothiazideDRUG

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at Screening
  • Outpatients
  • With newly diagnosed and untreated OR previously diagnosed, treated and uncontrolled Isolated Systolic Hypertension defined as:
  • seated Systolic Blood Pressure (SBP) ≥ 160mmHg and \< 220 mmHg \[160-220\[
  • AND seated Diastolic Blood Pressure (DBP)\< 90 mmHg
  • at Randomization
  • Having completed the 2 to 4-week wash-out/placebo run-in phase
  • Still eligible for Blood Pressure
  • seated SBP ≥ 160mmHg and \< 220 mmHg \[160-220\[
  • AND seated DBP \< 90 mmHg.

You may not qualify if:

  • Participation in a clinical trial within the previous 3 months
  • Patients with a history of irbesartan, amlodipine, or hydrochlorothiazide sensitivity defined as irbesartan, amlodipine, or hydrochlorothiazide discontinuation due to medically significant adverse effects
  • Patients currently or previously treated with Angiotensin II Receptor Blocker (irbesartan, losartan, candesartan, valsartan, telmisartan, etc.) or dihydropiridine Calcium Channel Blocker (amlodipine, nicardipine, felodipine, nifedipine, etc.) AND not responding despite maximum tolerated dose
  • Known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.)
  • Known single functional kidney
  • History of recent myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty, or cerebrovascular accident (Transient Ischaemic Attack, stroke) within the last 6 months of study entry
  • Patients with known gastrointestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease which in the opinion of the investigator is active or uncontrolled
  • Patients with significant renal (clearance of creatinine \< 30 mL/mn), hepatic or cardiac insufficiency, or known valvular heart disease
  • Serum potassium \< 3.5 mmol/L (mEq/L) or \> 5.5 mmol/L (mEq/L)
  • Presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or QTc prolongation (Bazett \> 450 msec.) on the ECG
  • Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sanofi-Aventis

Santiago, Chile

Location

Sanofi-Aventis

Shanghai, China

Location

Sanofi-Aventis

Jakarta, Indonesia

Location

Sanofi-Aventis

México, Mexico

Location

Sanofi-Aventis

Manila, Philippines

Location

Sanofi-Aventis

Seoul, South Korea

Location

Sanofi-Aventis

Taipei, Taiwan

Location

Sanofi-Aventis

Bangkok, Thailand

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Pascale BLONDIN, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

August 1, 2004

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

CL(1)KR(1)CN(1)PH(1)TH(1)ID(1)TW(1)ME(1)