ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Irbesartan - Hydrochlorothiazide

• Registration Number: NCT00708344
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-02
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-15
• Last Update Posted: 2010-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 832

Inclusion Criteria

• 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

Exclusion Criteria

• 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Irbesartan - Hydrochlorothiazide	Usual elective titration regimen
Group 2	Irbesartan - Hydrochlorothiazide	Active elective titration regimen

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇻🇪 Caracas, Venezuela