Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-02 @ 6:44 PM
Study NCT ID:
NCT00990834
Status:
WITHDRAWN
Last Update Posted:
2015-05-22
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Characteristics Associated With Statin Therapy
Sponsor:
Scripps Health
Organization:
Study Overview
Official Title:
Muscle Characteristics Associated With Statin Therapy
Status:
WITHDRAWN
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit subjects.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.
Detailed Description:
Statins have been proven to reduce cardiovascular events and mortality in large clinical trials but remain underutilized partly due to the associated myopathy. Severe reactions manifested as rhabdomyolysis are rare but myalgia is commonly noted in clinical practice. The pathophysiology of these events remains obscure. Previous studies suggest that statins block the downstream products (such as cellular signaling molecules) of the mevalonate pathway needed for normal muscle function. Other studies show that statins are associated with gene expressions involved in muscle damage such as atrogin-1. We will quantify these entities pre and post statin therapy to better understand these reactions.
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?: