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Lipid Lowering in Patients With Statin Intolerance

NCT ID: NCT00405769

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-10-31

Brief Summary

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This study will attempt to further validate a clinical treatment plan to lower LDL values using non-prescription supplements combined with a lifestyle change and education program which could represent an alternative approach to improve compliance in group of people who are unable to take traditional medication to lower cholesterol.

Detailed Description

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Up to 70 participants will be randomized into 2 groups. Each shall have similar total and LDL cholesterol values obtained prior to the study. Study Group 1 will participate in the Change of Heart Program (an intensive program to make therapeutic lifestyle changes) and take a placebo pill. Study Group 2 will also participate in Change of Heart. Group 2 will be provided an over the counter supplement consisting of red rice yeast 2.4-3.6 gms day)

Blood work consisting of a lipid panel, cardiac CRP, CPK, liver function panel and TSH will be obtained prior to study, and at 12 and 26 wks. Questionnaires will be administered regarding quality of life indexes, and ancillary symptom relief (i.e. degree of arthritis discomfort, generalized weakness) before, 12 and 26 weeks. After the Change of Heart program ends (12 weeks), participants will continue on study medication for a total of 6 months. A final questionnaire and final blood work will be obtained at 6 months, and at that point, medications can be discontinued.

Conditions

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Hyperlipidemia Coronary Artery Disease

Keywords

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statin intolerance hyperlipidemia lifestyle changes red yeast rice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

placebo control

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

3 caps bid

2

red yeast rice

Group Type ACTIVE_COMPARATOR

red yeast rice

Intervention Type DRUG

600 mg 3 caps bid

Interventions

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red yeast rice

600 mg 3 caps bid

Intervention Type DRUG

placebo

3 caps bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Baseline cholesterol - LDL more than 160 with one risk factor or LDL more than 130 with 2 or more risk factors for developing coronary artery disease (Smoker, age \>40, male, Family history, diabetes, obesity) utilizing ATP III guidelines
2. Have had a statin prescribed by a doctor for high cholesterol, and have stopped medication because of side effects
3. Ability to exercise without physical restrictions
4. Ability to attend 12 week consecutive Change of Heart sessions
5. Not taking any cholesterol lowering medication for at least 1 month prior to initiation of trial. Not taking red yeast rice for at least 1 month prior.

Exclusion Criteria

1. Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year
2. Known intolerance to one of the study drugs
3. Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease
4. Uncontrolled hypertension (defined as SBP\>180 mmHg or DBP \> 100mmHg.
5. Heart attack, bypass surgery, or angioplasty/stent within 1 year of study
6. Triglyceride level more than 400 mg/dl
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chestnut Hill Health System

OTHER

Sponsor Role lead

Principal Investigators

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David J Becker, MD

Role: PRINCIPAL_INVESTIGATOR

Chestnut Hill Health System

Locations

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Chestnut Hill Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Becker DJ, Gordon RY, Halbert SC, French B, Morris PB, Rader DJ. Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):830-9, W147-9. doi: 10.7326/0003-4819-150-12-200906160-00006.

Reference Type DERIVED
PMID: 19528562 (View on PubMed)

Other Identifiers

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FWA00005390

Identifier Type: -

Identifier Source: org_study_id