NCT00639223

Brief Summary

This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle pain. The study will determine whether red yeast is associated with a lower level of muscle related complaints compared to pravastatin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed
Last Updated

January 18, 2010

Status Verified

December 1, 2009

Enrollment Period

6 months

First QC Date

March 14, 2008

Results QC Date

December 9, 2009

Last Update Submit

December 9, 2009

Conditions

HypercholesterolemiaStatin-Associated Myopathy

Keywords

Statin related myalgiaHyperlipidemiaRed yeast riceCardiovascular DiseasesNutritional and Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500

    12 weeks

Secondary Outcomes (1)

  • Change in LDL-Cholesterol Measured at the Beginning and End of the Study

    12 weeks

Study Arms (2)

Pravastatin

ACTIVE COMPARATOR
Drug: PravastatinBehavioral: Lifestyle modification program

Red yeast Rice

EXPERIMENTAL
Dietary Supplement: Red Yeast RiceBehavioral: Lifestyle modification program

Interventions

Red Yeast RiceDIETARY_SUPPLEMENT

Four 600mg capsules twice daily for 12 weeks

Red yeast Rice
PravastatinDRUG

One 20mg capsule twice daily for 12 weeks

Also known as: Pravachol
Pravastatin
Lifestyle modification programBEHAVIORAL

Weekly sessions each lasting 3 1/2 hours for 12 weeks

PravastatinRed yeast Rice

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject reports stopping at least one statin drug due to complaints of muscle pain or weakness which his/her physician thinks was attributable to the drug.
  • Subject has never taken pravastatin.
  • Subject willing to remain off the dietary supplements CoQ10, L-carnitine, fish oil, policosanol, and guggulipid, garlic, and phytosterols in margarines (e.g. Benecol, Promise activ), milk or cereal products, for one month prior to the trial and for the duration of the trial.

You may not qualify if:

  • A history of muscle damage (CK\>1000 IU) on statin therapy.
  • A history of generalized chronic pain such as fibromyalgia, or generalized arthritis.
  • Any active cardiac problem including chest pain, angina, heart attack, bypass surgery, angioplasty/stent or unstable angina/acute coronary syndrome within the past 6 months.
  • Taking other lipid lowering drugs including: ezetimibe, gemfibrozil, niacin, fibrates or bile acid sequestrants.
  • Triglyceride level more than 400 mg/dl.
  • Taking weight loss medication including orlistat, sibutramine, diethylpropion, phendimetrazine, phentermine.
  • Taking pain medication or systemic steroids on a chronic basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chestnut Hill Hospital

Philadelphia, Pennsylvania, 19118, United States

Location

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemiasCardiovascular DiseasesNutritional and Metabolic Diseases

Interventions

red yeast ricePravastatin

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Limitations and Caveats

Small sample size precluded definitive conclusions.

Results Point of Contact

Title
Steven Halbert MD, MSCE
Organization
U. of Pennsylvania Health System
shalbert@mail.med.upenn.edu
215 510 2221

Study Officials

  • Steven C Halbert, MD

    University of Pennsylvania

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

October 1, 2008

Last Updated

January 18, 2010

Results First Posted

January 18, 2010

Record last verified: 2009-12

Locations

US(1)