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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-4s7gh3 |
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Date of registration:
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02/03/2011 |
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Primary sponsor: |
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Public title:
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PREVER Study: Efficacy of Chlorthalidone associated with Amiloride versus Losartan in reducing blood pressure of patients with hypertension Prever 2 Study
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Scientific title:
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PREVER Study: Efficacy of Chlorthalidone associated with Amiloride versus Losartan in reducing blood pressure of patients with hypertension Prever 2 Study
- PREVER 2: Prevention of Cardiovascular outcomes in patients with hypertension |
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Date of first enrolment:
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01/02/2011 |
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Target sample size:
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2400 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-4s7gh3/ |
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Study type:
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Study design:
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Double-blind Randomized Clinical Trial
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Flávio
Fuchs |
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Address:
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Rua Ramiro Barcelos 2350 2º Andar Serviço de Cardiologia
90035-903
Porto Alegre
Brazil |
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Telephone:
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51 33598449 |
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Email:
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ffuchs@hcpa.ufrgs.br |
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Affiliation:
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Hospital de Clínicas de Porto Alegre |
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Name:
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Flávio
Fuchs |
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Address:
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Rua Ramiro Barcelos 2350 2º Andar Serviço de Cardiologia
90035-903
Porto Alegre
Brazil |
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Telephone:
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51 33598449 |
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Email:
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ffuchs@hcpa.ufrgs.br |
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Affiliation:
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Hospital de Clínicas de Porto Alegre |
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Key inclusion & exclusion criteria
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Inclusion criteria: I. Individuals with 40 to 70 years, of both sexes;
II. Diagnosis of Hypertension in stage I, ie, systolic (SBP) between 140-159 mmHg or diastolic blood pressure (DBP) between 90-99 mmHg
Exclusion criteria: I. Chronic diseases that reduce life expectancy or difficulty in understanding the guidelines, which limit the possibility of participation in the study;
II. Refusal to participate or sign an informed consent;
III. Pregnancy or women most likely to become pregnant during the study;
IV. Known allergy to any of the study drugs;
V. Prior diagnosis of secondary hypertension ;
Age minimum:
40Y
Age maximum:
70Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Hypertension
I10
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Intervention(s)
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Drug: Chlorthalidone 12,5 mg associated with Amiloride 2,5 mg once daily
Drug: Losartan 25 mg once daily
During 18 months.
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Primary Outcome(s)
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I. Lowering blood pressure to less than 140/90 mmHg;
II. Incidence of Adverse Events;
III. Incidence of diabetes mellitus, microalbuminuria, hypokalemia, hiperuricemia and left ventricular hypertrophy on ECG.
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Secondary Outcome(s)
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I. All-cause mortality
II. Incidence of Coronary Artery Disease (Acute Coronary Syndrome, need for revascularization, sudden death)
III. Fatal and nonfatal stroke
IV. Heart failure (requiring hospitalization)
V. Duplication of plasma levels of creatinine or need for dialysis
VI. Incidence of diabetes mellitus.
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Secondary ID(s)
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08621
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NCT00971165
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Source(s) of Monetary Support
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FINEP - Brazil
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