Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• 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(140mmHg and 90

Exclusion Criteria:

• 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