CClinicalTrials.gg
Status unknownNCT00704548Updated Jun 26, 2009

Antihypertensive Effect of Simvastatin in Hypertensive Patients

A Phase 4 interventional study of Simvastatin 40mg and Placebo in Hypertension, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-06-26.

Sponsored by Hospital de Clinicas de Porto Alegre · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 92 is close to the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hypertensive patients with controlled or uncontrolled blood pressure

Exclusion criteria

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).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
92 participants (estimated)

Study arms

  • Active comparator
    1

    Simvastatin 40 mg

    Drug: Simvastatin 40mg

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugSimvastatin 40mg

    Simvastatin once daily, orally in the morning period, during eigth weeks

  • DrugPlacebo

    Placebo once daily, orally in the morning period, during eigth weeks

06

What researchers measure

Primary outcomes

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

    Time frame: Eigth weeks

07

Study locations

1 of 1 sites recruiting
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    • Miguel Gus, MD · Contact · mgus@terra.com.br · +55512101-8420
    • Miguel Gus, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00704548
Lead sponsor
Hospital de Clinicas de Porto Alegre
First posted
Jun 25, 2008
Start date
Jun 2008
Primary completion
Sep 2009 (estimated)
Completion
Sep 2009 (estimated)
Last update
Jun 26, 2009

Study contacts

Miguel Gus, MD
Contact
mgus@terra.com.br
+55512101-8420
Miguel Gus, MD
principal investigator · Hospital de Clinicas de Porto Alegre
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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