ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination
NCT ID: NCT00708344
Last Updated: 2010-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
832 participants
INTERVENTIONAL
2008-06-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Usual elective titration regimen
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
Group 2
Active elective titration regimen
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Nathalie - GENES, MD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Algiers, , Algeria
Sanofi-Aventis Administrative Office
Buenos Aires, , Argentina
Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Sanofi-Aventis Administrative Office
Bogotá, , Colombia
Sanofi-Aventis Administrative Office
Quito, , Ecuador
Sanofi-Aventis Administrative Office
Cairo, , Egypt
Sanofi-Aventis Administrative Office
Guatemala City, , Guatemala
Sanofi-Aventis Administrative Office
Beirut, , Lebanon
Sanofi-Aventis Administrative Office
Col. Coyoacan, , Mexico
Sanofi-Aventis Administrative Office
Casablanca, , Morocco
Sanofi-Aventis Administrative Office
Panama City, , Panama
Sanofi-Aventis Administrative Office
Lima, , Peru
Sanofi-Aventis Administrative Office
Jeddah, , Saudi Arabia
Sanofi-Aventis Administrative Office
Mégrine, , Tunisia
Sanofi-Aventis Administrative Office
Dubai, , United Arab Emirates
Sanofi-Aventis Administrative Office
Caracas, , Venezuela
Countries
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References
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Girerd X, Rosenbaum D, Aoun J; ACTUAL study Investigators. Efficacy and safety of early versus late titration of fixed-dose irbesartan/hydrochlorothiazide: ACTUAL study. Blood Press Suppl. 2011 Dec;2:22-9. doi: 10.3109/08037051.2011.633368.
Other Identifiers
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IRBEH_R_02931
Identifier Type: -
Identifier Source: org_study_id
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