Antihypertensive Effect of Simvastatin in Hypertensive Patients

Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring

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

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Drug: Simvastatin 40mg; Drug: Placebo

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
• Enrollment (Anticipated): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Miguel Gus, MD; Phone Number: +55512101-8420; Email: mgus@terra.com.br
      • Principal Investigator: Miguel Gus, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: Placebo; Placebo once daily, orally in the morning period, during eigth weeks
ACTIVE_COMPARATOR: 1; Simvastatin 40 mg	Drug: Simvastatin 40mg; Simvastatin once daily, orally in the morning period, during eigth weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM)	Eigth weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ANTICIPATED): September 1, 2009
• Study Completion (ANTICIPATED): September 1, 2009

Study Registration Dates

• First Submitted: June 23, 2008
• First Submitted That Met QC Criteria: June 23, 2008
• First Posted (ESTIMATE): June 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 26, 2009
• Last Update Submitted That Met QC Criteria: June 25, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: 08014