Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00405769
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00405769
Study Brief:
Protocol Section:
NCT00405769