NCT00704548

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 26, 2009

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

June 23, 2008

Last Update Submit

June 25, 2009

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

    Eigth weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Simvastatin 40 mg

Drug: Simvastatin 40mg

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Simvastatin 40mgDRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertensive patients with controlled or uncontrolled blood pressure

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Miguel Gus, MD

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Gus, MD

CONTACT

+55512101-8420mgus@terra.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 25, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 26, 2009

Record last verified: 2009-06

Locations

BR(1)