Try our beta test site

Antihypertensive Effect of Simvastatin in Hypertensive Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
Information provided by:
Hospital de Clinicas de Porto Alegre Identifier:
First received: June 23, 2008
Last updated: June 25, 2009
Last verified: June 2009

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
Drug: Simvastatin 40mg
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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 ]

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00704548

Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Principal Investigator: Miguel Gus, MD Hospital de Clinicas de Porto Alegre
  More Information

Responsible Party: Miguel Gus, Hospital de Clínicas de Porto Alegre Identifier: NCT00704548     History of Changes
Other Study ID Numbers: 08014 
Study First Received: June 23, 2008
Last Updated: June 25, 2009

Additional relevant MeSH terms:
Antihypertensive Agents
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on February 20, 2017