Diuretics and Angiotensin-Receptor Blocker Agents in Patients With Stage I Hypertension (PREVER)
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|ClinicalTrials.gov Identifier: NCT00971165|
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : February 12, 2015
High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence of hypertension in Brazil was established in population-based studies conducted in different cities and States, varying from 22.3 to 44% of adults.
The benefit of drug treatment of hypertension to prevent major cardiovascular events was consistently demonstrated in a large series of clinical trials controlled by placebo.
Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride.
A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order to support the decisions of the Health Secretary in regard to blood pressure agents supply for the Brazilian population. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Cardiovascular Disease||Drug: losartan Drug: Chlorthalidone plus amiloride||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||655 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Comparison Between Diuretics and Angiotensin-receptor Blocker Agents in Patients With Stage I Hypertension: PREVER-treatment Study|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Active Comparator: Chlorthalidone plus amiloride
Oral Chlorthalidone plus amiloride up to 25 e 5 mg daily for 18 months
Drug: Chlorthalidone plus amiloride
Oral Chlorthalidone plus amiloride up to 25 e 5 mg daily, once a day for 18 months
Other Name: diuretics
Oral losartan up to 100 mg daily, once a day, for 18 month
Oral losartan up to 100 mg daily fo 18 months
- Blood pressure variation and proportion of use of add-on drugs [ Time Frame: 18 months ]
- Adverse events [ Time Frame: 18 months ]
- Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. [ Time Frame: 18 monyhs ]
- fatal or major cardiovascular events: myocardial infarction, stroke, coronary interventions, heart failure, duplication of creatinine [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971165
|Hospital de Clínicas de Porto Alegre, UFRGS|
|Porto Alegre, RS, Brazil, 90035 903|
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, RS, Brazil, 90035-903|
|Study Chair:||Flávio D Fuchs, MD, PhD||Hospital de Clínicas de Porto Alegre|