Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

All of the following criteria must be answered “Yes”:
1. Patient is 21 years of age or older and willing to participate for the duration of the study;
2. Patient has read, signed, and agreed to the items listed in the informed consent form and HIPAA authorization form prior to the initiation of any study procedures and/or discontinuing any medications;
3. Patient is eligible for treatment following the drug washout period based upon the NCEP ATP III entry criteria and the LDL-C variability ≤ 15%;
4. Patient has mean triglyceride level (TG) ≤ 300 mg/dL;
5. Patient is willing to withdraw from any current anti-dyslipidemic medications or other prohibited medication for approximately 6 weeks prior to randomization (4 weeks prior to qualification visits) and for the duration of the study;
6. If the patient is female, the patient must not be pregnant or breast-feeding and not planning to become pregnant or to breast-feed for the duration of the study. Women of childbearing potential must commit to using a medically acceptable method of birth control such as oral contraception, intrauterine device (IUD), or a double-barrier method of contraception. Women using oral contraception must have done so for at least 3 months prior to randomization, and continue to do so for the duration of the study. To be considered not of childbearing potential, women must be post-menopausal for at least 2 years or surgically sterile.

Exclusion Criteria

All the following criteria must be answered “No”:
1. Patient has an allergy, hypersensitivity, or intolerance to niacin, simvastatin, atorvastatin, ezetimibe, rosuvastatin or their derivatives;
2. Patient drinks more than 14 alcoholic drinks per week or has a previous history (within 12 months of screening) of substance abuse or dependency;
3. Patient has untreated or unsuccessfully treated psychiatric disease;
4. Patient has used an investigational study medication or participated in an investigational study within 30 days of obtaining qualification labs;
5. Patient has taken a prohibited medication within 4 weeks of obtaining qualification labs for the study (See section 8.0 - Concomitant Medications);
6. Patient has a history of any of the following:
- active gallbladder disease within the preceding 12 months (cholecystectomy is allowed);
- pancreatitis;
- liver disease (e.g., hepatitis B and/or C);
- persistent uncontrolled or untreated severe hypertension;
- Type I or Type II diabetes;
- persistent uncontrolled or untreated hypothyroidism;
- arterial bleeding;
- unstable angina;
- myocardial infarction, coronary artery bypass graft surgery, or angioplasty within the preceding 6 months;
- stroke, transient ischemic attack (TIA), or deep vein thrombosis (DVT) within the preceding 6 months;
- congestive heart failure NYHA class III or IV;
- active cancer within the last 5 years or a diagnosis of cancer within the last 5 years (excluding basal cell carcinoma);
- fibromyalgia, myopathy, rhabdomyolysis, unexplained muscle pain or weakness, and/or discontinuation of a statin because of myalgia; and/or
- life expectancy < 2 years.
7. Patient has any of the following abnormalities at any of the Screening or Qualification Visits:
- CPK elevation > 3xULN;
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.3xULN;
- serum creatinine ≥ 1.5 mg/dL;
- creatinine clearance < 30 mL/min, as calculated using the Cockroft and Gault formula by the central laboratory;
- active gout symptoms and/or uric acid level > 1.3xULN;
- and/or active peptic ulcer disease;
8. Patient is planning to undergo major surgery within the next 6 months;
9. Patient has any health condition or laboratory abnormality that, in the opinion of the Principal Investigator, may be adversely affected by the procedures or medications in this study.