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Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

NCT00669695 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-09-24

No results posted yet for this study

Summary

The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of treatment, by a double-blind, randomized, placebo-controlled, multi-center study.

An interim analysis will be performed when 25 patients per group will be included.

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

DRUG

Atorvastatin treatment

Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.

OTHER

CPAP device

This device consists in a nasal continuous positive airway pressure (CPAP). It will be applied 3 months after the beginning of drug treatment and for 3 months.

OTHER

sham CPAP treatment

This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Louis PEPIN, MD, PhD · University Hospital of Grenoble, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • France
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669695 on ClinicalTrials.gov