Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127335
Status:
WITHDRAWN
Last Update Posted:
2022-11-23
First Post:
2005-08-04
Brief Title:
Is Myopathy Part of Statin Therapy IMPOSTER-16
Sponsor:
Scripps Health
Organization:
Scripps Health
Study Overview
Official Title:
Double Blind Prospective Randomized Crossover Study of Patients With Muscle Complaints on Statin Therapy
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is a significant proportion of patients complaining of muscle symptoms while on statin therapy who have a measurable difference in muscle strength or endurance and whose muscle biopsies are diagnostic for myopathy
Detailed Description:
This is a double-blinded randomized placebo-controlled crossover trial Sixty patients who are identified by their physician as having muscle pain or weakness while on statin therapy and in whom creatine kinase CK enzyme determinations have been normal will be enrolled voluntarily All patients will have a percutaneous muscle biopsy prior to enrollment into the trial These patients will be randomized in a blinded crossover fashion to either standardized statin therapy or placebo in eight week intervals After eight weeks of drug or placebo the patients will be assessed for signs and symptoms of muscle weakness by
Dynamometry of grip and hip strength
An exercise test with exhaled gas analysis
Blood tests for cholesterol creatine kinase lactate
Urine tests for organic acids
Following the first eight-week study and testing period each patient will serve as their own control and they will enter a second eight-week study period During the second phase they will take the opposite therapy either drug or placebo which they have not yet received Sub-studies will include ten controls who have never previously received statins and ten subjects who have suffered statin-induced rhabdomyolysis Subjects in these sub-studies will not be exposed to statin therapy and will only undergo limited testing
Dynamometry of grip and hip strength
An exercise test with exhaled gas analysis
Blood tests for cholesterol creatine kinase lactate
Urine tests for organic acids
Following the first eight-week study and testing period each patient will serve as their own control and they will enter a second eight-week study period During the second phase they will take the opposite therapy either drug or placebo which they have not yet received Sub-studies will include ten controls who have never previously received statins and ten subjects who have suffered statin-induced rhabdomyolysis Subjects in these sub-studies will not be exposed to statin therapy and will only undergo limited testing
Study Oversight
Has Oversight DMC:
None
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?:
None