ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

Hypertension Clinical Trial

— ACTUAL  

Official title:

Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination: A Comparison of Active and Usual Titration Regimen in the Treatment of Hypertensive Patients Insufficiently Controlled by Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708344
• Other study ID #: IRBEH_R_02931
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2008
• Last updated: July 15, 2010
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 832
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Irbesartan - Hydrochlorothiazide
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
• Irbesartan - Hydrochlorothiazide
150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Treatment duration : 10 weeks

Locations

Country	Name	City	State
Algeria	Sanofi-Aventis Administrative Office	Algiers
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Colombia	Sanofi-Aventis Administrative Office	Bogota
Ecuador	Sanofi-Aventis Administrative Office	Quito
Egypt	Sanofi-Aventis Administrative Office	Cairo
Guatemala	Sanofi-Aventis Administrative Office	Guatemala City
Lebanon	Sanofi-Aventis Administrative Office	Beirut
Mexico	Sanofi-Aventis Administrative Office	Col. Coyoacan
Morocco	Sanofi-Aventis Administrative Office	Casablanca
Panama	Sanofi-Aventis Administrative Office	Panama
Peru	Sanofi-Aventis Administrative Office	Lima
Saudi Arabia	Sanofi-Aventis Administrative Office	Jeddah
Tunisia	Sanofi-Aventis Administrative Office	Megrine
United Arab Emirates	Sanofi-Aventis Administrative Office	Dubaï
Venezuela	Sanofi-Aventis Administrative Office	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Algeria,  Argentina,  Brazil,  Colombia,  Ecuador,  Egypt,  Guatemala,  Lebanon,  Mexico,  Morocco,  Panama,  Peru,  Saudi Arabia,  Tunisia,  United Arab Emirates,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean Systolic Blood Pressure		between Visit 1 (Week 0) and Visit 4 (Week 10)	No
Secondary	Change in mean Diastolic Blood Pressure		between Visit 1 (Week 0) and Visit 4 (Week 10)	No