Clinical TrialID 339

Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance

NCT00639223

Hypercholesterolemia|Statin-Associated Myopathy

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
339
Evidence Id
339
Core Evidence Id
339
Source Clinical Trial Id
325
Herb2 Clinical Trial Id
HBCT000325
Nct Id
NCT00639223
Title
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
Status
Completed
Phase
Phase 2
Study Result
Yes
Study Condition
Hypercholesterolemia|Statin-Associated Myopathy
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DIETARY_SUPPLEMENT: Red Yeast Rice|DRUG: Pravastatin|BEHAVIORAL: Lifestyle modification program
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
43
Outcome Measure
Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500, 12 weeks
Sponsor Collaborator
University of Pennsylvania|Chestnut Hill Health System
Funded By
OTHER
Location
Chestnut Hill Hospital, Philadelphia, Pennsylvania, 19118, United States
Other Id
806827
Start Date
2008-01
Primary Completion Date
2008-07
Completion Date
2008-10
First Posted
2008-03-20
Results First Posted
2010-01-18
Last Update Posted
2010-01-18
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00639223
Title Cn
Title En
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
Bilingual Status
semi_complete