Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia
Brief Summary: To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.


Options:
A: Inclusion Criteria:

* Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
* Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

* Pregnant or lactating women or intending to become pregnant
* Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
* Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
* Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk
B: Inclusion Criteria:

* HIV positive
* On stable HAART regimen for at least 6 months prior to study entry
* T-cell count greater than 100 and viral load less than 1,000 for at least 6 months prior to study entry
* Fasting triglyceride level greater than 150 mg/dl
* Body mass index (BMI) greater than 18.5 and less than 30
* Uses barrier contraception

Exclusion Criteria:

* Fasting triglyceride level greater than 1000 mg/dl
* BMI less than 18.5 or greater than 30
* Taking diabetic medication or HbA1c less than 7.0
* Use of lipid lowering medication in the 30 days prior to study entry
* Unable to exercise
* T-cell count less than 100
* Current medical condition that makes exercise unadvisable
* History of coronary artery disease (CAD)
* Use of dietary supplements (within 30 days of study entry) that may affect lipid levels including, but not limited to, the following:

  1. Omega-3 fatty acids
  2. L-Carnitine
  3. Soluble fiber supplements
  4. Guggul
  5. Garlic supplements
  6. Niacin greater than 25mg/d
  7. Oral liquid supplements
* Use of steroids, hormones, or testosterone (without diagnosis of hypogonadism, testosterone less than 300 ng/dl)
* Irregular periods
* Depo-Provera
* Hypo- or Hyperthyroidism
* Adrenal insufficiency
* Serum alanine or aspartate aminotransferase level greater than 3 times the upper limit of normal
* Alcohol abuse
* Renal insufficiency (creatinine level greater than 1.5 mg/dl)
* Coumadin therapy
* Pregnancy
* Peptic ulcer disease
* Cholelithiasis
* History of hyperuricemia
* History of myositis or rhabdomyolysis
* Known adverse reaction to niacin or fibrates
* Hepatitis C therapy
C: Inclusion Criteria:

* Patient has primary Type II hyperlipidemia or mixed dyslipidemia.
* If the patient is currently taking a lipid modifying medication other than Zocor \& he/she is willing to discontinue this medication
* LDL-C levels and/or non HDL-C levels above normal.
* Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.

Exclusion Criteria:

* Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
* HbA1c ≥ 9% in diabetic patients
D: Inclusion Criteria:

* History of myocardial infarction; or
* Cerebrovascular atherosclerotic disease (history of presumed ischaemic stroke, transient ischaemic attack or carotid revascularisation)
* Peripheral arterial disease (i.e. intermittent claudication or history of revascularisation); or
* Diabetes mellitus with any of the above or with other evidence of symptomatic coronary heart disease (i.e. stable or unstable angina, or a history of coronary revascularisation or acute coronary syndrome).

Exclusion Criteria:

* Age \<50 or \>80 years at invitation to Screening;
* Less than 3 months since presentation with acute myocardial infarction, coronary syndrome or stroke (but such patients may be entered later, if appropriate);
* Planned revascularisation procedure within 3 months after randomization (but such patients may be entered later, if appropriate);
* Definite history of chronic liver disease, or abnormal liver function (i.e. Alanine transaminase (ALT) \>1.5 times upper limit of normal (ULN). (Note: Patients with a history of acute hepatitis are eligible provided this ALT limit is not exceeded);
* Breathlessness at rest for any reason;
* Severe renal insufficiency (i.e. creatinine \>200 µmol/L);
* Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or Creatine kinase (CK) \>3 times upper limit of normal (3xULN);
* Previous significant adverse reaction to a statin, ezetimibe, niacin or laropiprant;
* Active peptic ulcer disease;
* Concurrent treatment with:
* fibric acid derivative ("fibrate")
* niacin (nicotinic acid) at doses more than 100 mg daily
* ezetimibe in combination with either simvastatin 80 mg, or atorvastatin 20-80 mg, or rosuvastatin 10-40 mg daily
* any potent cytochrome P450 3A4 (CYP3A4) inhibitor, including: macrolide antibiotics (erythromycin, clarithromycin, telithromycin); systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole); protease inhibitors (antiretroviral drugs for HIV infection); and nefazodone
* ciclosporin
* amiodarone
* verapamil
* danazol (Note: Patients who are temporarily taking such drugs may be re-screened when they discontinue them, if considered appropriate.);
* Known to be poorly compliant with clinic visits or prescribed medication;
* Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer or evidence of spread within last 5 years other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)

Answer: A