Status:
TERMINATED
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 do...
Detailed Description
Secondary objectives of this clinical trial : * To evaluate the effect of Atorvastatin in comparison with the placebo on the inflammation occurring during OSAS, after 3 months of treatment. * To eval...
Eligibility Criteria
Inclusion
- Men or women \> 18 years old
- Subjects diagnosed with OSAS (apnea/hypopnea index = AHI \> 30/h)
- Subjects with clinical ATH from grade I or II controlled with mono-therapy(140\<SAP\<180 mmHg and 90\<DAP\<110 mmHg)
Exclusion
- Patients with a history of prior stroke or coronary ischemic disease
- Chronic respiratory disease (PaO2 \< 60 mmHg and/or PaCO2 \> 45 mmHg)
- Lung disease
- Hypothyroidism
- Statin treatment
- Antihypertensive treatment with more than one drug
- Pregnant or lactating women
- Alcohol consumption \> 3 units/day
- Treatment by itraconazole, ketoconazole, antiprotease, fibrates, antivitamin K, diltiazem, verapamil, erythromycin, clarithromycin, cyclosporin.
- Hypersensitivity to one of the drug compounds
- Patients with modified concomitant treatments during the 3 months before inclusion
- Potentially dangerous sleepiness
- Jobs at risk
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00669695
Start Date
May 1 2008
End Date
February 1 2013
Last Update
September 24 2013
Active Locations (4)
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1
Universitary Hospital of Angers
Angers, France, 49033
2
Hospital of Annemasse
Annemasse, France, 74017
3
University Hospital of Grenoble
Grenoble, France, 38043
4
Universitary Hospital of Geneva
Geneva, Switzerland, 1211