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Antihypertensive Effect of Simvastatin in Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT00704548
Recruitment Status : Unknown
Verified June 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : June 25, 2008
Last Update Posted : June 26, 2009
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Drug: Simvastatin 40mg Drug: Placebo Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring
Study Start Date : June 2008
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Simvastatin 40 mg
Drug: Simvastatin 40mg
Simvastatin once daily, orally in the morning period, during eigth weeks
Placebo Comparator: 2 Drug: Placebo
Placebo once daily, orally in the morning period, during eigth weeks



Primary Outcome Measures :
  1. Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM) [ Time Frame: Eigth weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertensive patients with controlled or uncontrolled blood pressure

Exclusion Criteria:

  • Secondary causes of hypertension;
  • Systolic Blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg
  • Complain of side effects related to Statins
  • Diabetes
  • Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease)
  • Renal disease (creatinine > 1,5 mgdl).

Information from the National Library of Medicine

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): NCT00704548


Contacts
Contact: Miguel Gus, MD +55512101-8420 mgus@terra.com.br

Locations
Brazil
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         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Miguel Gus, MD Hospital de Clinicas de Porto Alegre

Responsible Party: Miguel Gus, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00704548     History of Changes
Other Study ID Numbers: 08014
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: June 26, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Simvastatin
Antihypertensive Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors