Overview

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(140 mmHg 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