Status:
COMPLETED
ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination
Lead Sponsor:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
832 Patients enrolled
Trial Details
Trial ID
NCT00708344
Start Date
June 1 2008
End Date
July 1 2009
Last Update
July 16 2010
Active Locations (16)
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1
Sanofi-Aventis Administrative Office
Algiers, Algeria
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
São Paulo, Brazil
4
Sanofi-Aventis Administrative Office
Bogotá, Colombia