Brief Summary

To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

832

participants targeted

Target at P75+ for phase_4 hypertension

Timeline

Completed

Started Jun 2008

Shorter than P25 for phase_4 hypertension

Geographic Reach

16 countries

16 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

1.1 years study duration

Study Start

First participant enrolled

June 1, 2008

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed

Last Updated

July 16, 2010

Status Verified

July 1, 2010

Enrollment Period

1.1 years

First QC Date

June 27, 2008

Last Update Submit

July 15, 2010

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

Change in mean Systolic Blood Pressure
between Visit 1 (Week 0) and Visit 4 (Week 10)

Secondary Outcomes (1)

Change in mean Diastolic Blood Pressure
between Visit 1 (Week 0) and Visit 4 (Week 10)

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Usual elective titration regimen

Drug: Irbesartan - Hydrochlorothiazide

Group 2

ACTIVE COMPARATOR

Active elective titration regimen

Drug: Irbesartan - Hydrochlorothiazide

Interventions

Irbesartan - HydrochlorothiazideDRUG

150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks

Group 1

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Established essential hypertension treated for at least 4 weeks by one antihypertensive drug alone
With uncontrolled Blood Pressure (BP) defined as:
SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg in non diabetic patients
SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg in diabetic patients

You may not qualify if:

SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at V1
Known or suspected causes of secondary hypertension
Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney; history of renal transplant or only has one functioning kidney
Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (e.g.: Beta-blocker for angina, ACE-inhibitors for heart failure, etc…).
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 the study drugs:
Severe renal dysfunction (creatinine clearance \<30ml/min)
Known hypokaliemia (\< 3 mmol/L) , known hypercalcemia
Severe hepatic impairment, biliary cirrhosis, cholestasis
Inability to obtain a valid automatic BP measurement recording
Administration of any other investigational drug within 30 days prior to study entry and during the course of the study
Presence of any severe medical or psychological condition that, in the opinion of the investigator, indicate that participation in the study is not in the best interest of the subject.
Presence of any other conditions (e.g. geographic, social, etc) that would restrict or limit the subject participation for the duration of the study.
Pregnant or breast-feeding women
Women of childbearing potential not protected by effective contraceptive method of birth control
+1 more criteria

Contact the study team to confirm eligibility.