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Lipid Lowering in Patients With Statin Intolerance

This study has been completed.
Sponsor:
Information provided by:
Chestnut Hill Health System
ClinicalTrials.gov Identifier:
NCT00405769
First received: November 29, 2006
Last updated: October 30, 2007
Last verified: October 2007

November 29, 2006
October 30, 2007
January 2007
Not Provided
LDL-cholesterol levels at baseline, 12 weeks and 6 months in 2 groups in a lifestyle intervention program [ Time Frame: 24 weeks ]
LDL-cholesterol levels at baseline, 12 weeks and 6 in 3 groups in a lifestyle intervention program
Complete list of historical versions of study NCT00405769 on ClinicalTrials.gov Archive Site
HDL, TG, Total cholesterol, cardiac CRP, [ Time Frame: 24 weeks ]
HDL, TG, Total cholesterol, cardiac CRP,
Not Provided
Not Provided
 
Lipid Lowering in Patients With Statin Intolerance
Alternative Lipid Lowering in Patients With Statin Intolerance: Use of Red Yeast Rice and Therapeutic Lifestyle Changes in a Randomized, Placebo-Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Hyperlipidemia
  • Coronary Artery Disease
  • Drug: red yeast rice
    600 mg 3 caps bid
  • Drug: placebo
    3 caps bid
  • Placebo Comparator: 1
    placebo control
    Intervention: Drug: placebo
  • Active Comparator: 2
    red yeast rice
    Intervention: Drug: red yeast rice
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
October 2007
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00405769
FWA00005390
Not Provided
Not Provided
Chestnut Hill Health System
Not Provided
Principal Investigator: David J Becker, MD Chestnut Hill Health System
Chestnut Hill Health System
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP