Antihypertensive Effect of Simvastatin in Hypertensive Patients - Full Text View

Purpose

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

MedlinePlus related topics:

High Blood Pressure

ChemIDplus related topics:

Simvastatin

U.S. FDA Resources

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

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM) [ Time Frame: Eigth weeks ] [ Designated as safety issue: No ]

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704548

Contacts


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

Locations


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

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators


Principal Investigator:	Miguel Gus, MD	Hospital de Clinicas de Porto Alegre

More Information

Responsible Party:	Hospital de Clínicas de Porto Alegre ( Miguel Gus )
Study ID Numbers:	08014
First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00704548
Health Authority:	Brazil: National Committee of Ethics in Research

Study placed in the following topic categories:

Simvastatin

Vascular Diseases

Hypertension

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Cardiovascular Diseases

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Hospital de Clinicas de Porto Alegre
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00704548