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Trial record 16 of 232 for:    yeast

Lipid Lowering in Patients With Statin Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00405769
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : October 31, 2007
Sponsor:
Information provided by:
Chestnut Hill Health System

Tracking Information
First Submitted Date  ICMJE November 29, 2006
First Posted Date  ICMJE November 30, 2006
Last Update Posted Date October 31, 2007
Study Start Date  ICMJE January 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
LDL-cholesterol levels at baseline, 12 weeks and 6 months in 2 groups in a lifestyle intervention program [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2006)
LDL-cholesterol levels at baseline, 12 weeks and 6 in 3 groups in a lifestyle intervention program
Change History Complete list of historical versions of study NCT00405769 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
HDL, TG, Total cholesterol, cardiac CRP, [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2006)
HDL, TG, Total cholesterol, cardiac CRP,
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipid Lowering in Patients With Statin Intolerance
Official Title  ICMJE Alternative Lipid Lowering in Patients With Statin Intolerance: Use of Red Yeast Rice and Therapeutic Lifestyle Changes in a Randomized, Placebo-Controlled Trial
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Hyperlipidemia
  • Coronary Artery Disease
Intervention  ICMJE
  • Drug: red yeast rice
    600 mg 3 caps bid
  • Drug: placebo
    3 caps bid
Study Arms  ICMJE
  • Placebo Comparator: 1
    placebo control
    Intervention: Drug: placebo
  • Active Comparator: 2
    red yeast rice
    Intervention: Drug: red yeast rice
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2007)
64
Original Enrollment  ICMJE
 (submitted: November 29, 2006)
100
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00405769
Other Study ID Numbers  ICMJE FWA00005390
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Chestnut Hill Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David J Becker, MD Chestnut Hill Health System
PRS Account Chestnut Hill Health System
Verification Date October 2007

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