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

CompletadoFase 4ClinicalTrials.gov

ID: NCT00708344Tipo: INTERVENTIONALInicio: 1 de jun de 2008Fin estimado: 1 de jul de 2009

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Severe renal dysfunction (creatinine clearance \<30ml/min)
Known hypokaliemia (\< 3 mmol/L) , known hypercalcemia
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 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.

Intervenciones

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

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. Treatment duration : 10 weeks

Ubicaciones

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

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