NCT00500604|CompletedPhase 4

Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension

COSIMA2

A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension

Sanofi ClinicalTrials.gov

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1 other identifier

IRBEH_R_02584

Study Type

interventional

Target

1,617

Locations

14 countries

Sites

Timeline

RegisteredJul 2007

StartedJul 2007

CompletionJan 2010

Brief Summary

The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline. The secondary objectives are:

To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24
To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
To compare the difference in mean SBP evaluated by HBPM at week 16
To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24
To determine the incidence and severity of adverse events

Trial Health

On Track

Trial Health Score

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

Enrollment

1,617

participants targeted

Target at P75+ for phase_4 hypertension

Timeline

Completed

Started Jul 2007

Typical duration for phase_4 hypertension

Geographic Reach

14 countries

14 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

July 1, 2007

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed

Last Updated

July 19, 2010

Status Verified

July 1, 2010

Enrollment Period

2.5 years

First QC Date

July 11, 2007

Last Update Submit

July 16, 2010

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

Reduction in mean SBP as measured by HBPM
From week 0 to week 24

Secondary Outcomes (8)

Reduction in mean DBP as measured by HBPM
From week 0 to weeks 16 and 24
Reduction in mean morning and evening SBP as measured by HBPM
From week 0 to weeks 16 and 24
Reduction in mean morning and evening DBP as measured by HBPM
From week 0 to weeks 16 and 24
Reduction in mean SBP and mean DBP evaluated at the doctor's office
From week 0 to weeks 16 and 24
Number of normalised patients as measured by HBPM
From week 0 to weeks 16 and 24
+3 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

* period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks * period 2: One 150/12.5mg tablet every morning for 8 weeks. * period 3: One 300/12.5mg tablet every morning for 8 weeks. * period 4: Two 150/12.5mg tablets every morning for 8 weeks.

Drug: Irbesartan/hydrochlorothiazideDrug: Hydrochlorothiazide

B

ACTIVE COMPARATOR

* period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks * period 2: One 80/12.5mg tablet every morning for 8 weeks. * period 3: One 160/12.5mg tablet every morning for 8 weeks. * period 4: Two 80/12.5mg tablets every morning for 8 weeks.

Drug: Valsartan/hydrochlorothiazideDrug: Hydrochlorothiazide

Interventions

Irbesartan/hydrochlorothiazideDRUG

150/12.5mg tablet and 300/12.5mg tablet

Valsartan/hydrochlorothiazideDRUG

80/12.5mg tablet and 160/12.5mg tablet

HydrochlorothiazideDRUG

12.5 mg administered orally, once daily in the morning

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Established essential hypertension, untreated or treated but uncontrolled with treatment:
Office SBP ≥ 160 mmHg for untreated patients
Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive drug.
Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
ACE inhibitor / calcium channel blocker
Beta blocker / calcium channel blocker
Beta blocker / low dose diuretic
ACE inhibitor / low dose diuretic

You may not qualify if:

SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1
Known or suspected causes of secondary hypertension
Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
Type 1 diabetes mellitus
Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject
Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
Known contraindications to any of the study drugs
Concomitant use of any other antihypertensive treatment
Use of any of the investigational products for this study within the 3 months prior to the study
Inability to obtain a valid HBPM recording i.e., obesity, arm circumference \> 32 cm or arrhythmia
Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
Pregnant or breast-feeding women
Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
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.