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Red Yeast Rice and Phytosterols In Statin Intolerance

NCT00897975 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-07-18

No results posted yet for this study

Summary

Red yeast rice may be useful to lower cholesterol, especially in a population of patients who cannot tolerate traditional therapy with statins.

The addition of an over-the-counter phytosterol to red yeast rice may offer additional lipid lowering benefits when compared to red yeast rice alone.

These supplements will be given to all participants. Up to one-half will enroll in a lifestyle intervention program called Change of Heart and will be compared to patients who do not participate in the program. The study will last one year.

Conditions

Interventions

DIETARY_SUPPLEMENT

red yeast rice

600 mg 3 capsules bid

DRUG

phytosterol

phytosterol 450 mg 2 tabs bid with food

BEHAVIORAL

therapeutic lifestyle program

TLC - 12 weeks

DRUG

placebo

placebo

Sponsors & Collaborators

  • Chestnut Hill Health System

    lead OTHER

Principal Investigators

  • David J Becker, MD · Chestnut Hill Heathcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-11-30
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00897975 on ClinicalTrials.gov