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Antihypertensive Effect of Simvastatin in Hypertensive Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00704548
First received: June 23, 2008
Last updated: June 25, 2009
Last verified: June 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring

Resource links provided by NLM:

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

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: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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

No publications provided

Responsible Party: Miguel Gus, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00704548     History of Changes
Other Study ID Numbers: 08014
Study First Received: June 23, 2008
Last Updated: June 25, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Simvastatin
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013