Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2026-02-20 @ 1:32 PM
Study NCT ID:
NCT00669695
Status:
TERMINATED
Last Update Posted:
2013-09-24
First Post:
2008-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis performed without efficient results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StatinflaSAS
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 double-blind, randomized, placebo-controlled, multi-center study.
An interim analysis will be performed when 25 patients per group will be included.
An interim analysis will be performed when 25 patients per group will be included.
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 evaluate the effect of Atorvastatin in comparison with the placebo on the insulin-resistance associated to OSAS, after 3 months of treatment.
* To evaluate the effect of Atorvastatin in comparison with the placebo on the hypercholesterolemia associated to OSAS, after 3 months of treatment.
* To evaluate at 6 months, the effect of the continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with Atorvastatin, CPAP and placebo.
* To measure the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo, after 3 months of treatment.
* To evaluate the effect of Atorvastatin in comparison with the placebo on the inflammation occurring during OSAS, after 3 months of treatment.
* To evaluate the effect of Atorvastatin in comparison with the placebo on the insulin-resistance associated to OSAS, after 3 months of treatment.
* To evaluate the effect of Atorvastatin in comparison with the placebo on the hypercholesterolemia associated to OSAS, after 3 months of treatment.
* To evaluate at 6 months, the effect of the continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with Atorvastatin, CPAP and placebo.
* To measure the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo, after 3 months of treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-005286-35 | REGISTRY | ID RCB | View |