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Antihypertensive Effect of Simvastatin in Hypertensive Patients

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Simvastatin 40mg
Placebo
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Simvastatin 40 mg

Outcomes

Primary Outcome Measures

Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM)

Secondary Outcome Measures

Full Information

First Posted
June 23, 2008
Last Updated
June 25, 2009
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT00704548
Brief Title
Antihypertensive Effect of Simvastatin in Hypertensive Patients
Official Title
Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Simvastatin 40 mg
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Simvastatin 40mg
Intervention Description
Simvastatin once daily, orally in the morning period, during eigth weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily, orally in the morning period, during eigth weeks
Primary Outcome Measure Information:
Title
Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM)
Time Frame
Eigth weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Gus, MD
Phone
+55512101-8420
Email
mgus@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Gus, MD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Gus, MD
Phone
+55512101-8420
Email
mgus@terra.com.br
First Name & Middle Initial & Last Name & Degree
Miguel Gus, MD

12. IPD Sharing Statement

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Antihypertensive Effect of Simvastatin in Hypertensive Patients

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