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Sponsored by: |
Hospital de Clinicas de Porto Alegre |
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Information provided by: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT00704548 |
Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile.
The purpose of this study is to determine the effect of Simvastatin on the blood pressure
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Simvastatin 40mg Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring |
Estimated Enrollment: | 92 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Simvastatin 40 mg
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Drug: Simvastatin 40mg
Simvastatin once daily, orally in the morning period, during eigth weeks
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2: Placebo Comparator |
Drug: Placebo
Placebo once daily, orally in the morning period, during eigth weeks
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This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Miguel Gus, MD | +55512101-8420 | mgus@terra.com.br |
Brazil, Rio Grande do Sul | |
Hospital de Clinicas de Porto Alegre | Recruiting |
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903 | |
Contact: Miguel Gus, MD +55512101-8420 mgus@terra.com.br | |
Principal Investigator: Miguel Gus, MD |
Principal Investigator: | Miguel Gus, MD | Hospital de Clinicas de Porto Alegre |
Responsible Party: | Hospital de Clínicas de Porto Alegre ( Miguel Gus ) |
Study ID Numbers: | 08014 |
Study First Received: | June 23, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00704548 |
Health Authority: | Brazil: National Committee of Ethics in Research |
Simvastatin Vascular Diseases Hypertension |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |