Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Niacin ER/Lovastatin on Peak Walking Time and Claudication Onset Time in Patients With Intermittent Claudication
Brief Summary: The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication.

At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study.

Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.


Options:
A: Inclusion Criteria:

* Patients between the ages of 18 to 80 years with Type 2 Diabetes who are on a stable dose of antidiabetic medication for at least 3 months

Exclusion Criteria:

* Patients taking Cholestin, niacin (\>50 mg/day), fibrate therapy, hormonal contraceptives, intermittent Hormone Replacement Therapy, or certain corticosteroids
* Patients with any of the following conditions: active liver disease or kidney disease, poorly controlled high blood pressure, active peptic ulcer, or other heart or blood diseases
* Patients with abnormal laboratory results from a blood test that will be given before starting the study
B: 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
C: Inclusion Criteria:

* Aim 1: Carotid or peripheral arterial disease and HDL \<1mmol/L
* Aim 2: Coronary artery disease, type II diabetes and HDL \<1mmol/L

Exclusion Criteria:

The following will constitute exclusion criteria:

* Inability to provide informed consent,
* Known intolerance of a study drug,
* Use of niacin or a fibrate at time of screening,
* AST or ALT elevated above normal range at time of screening
* Use of oral nitrates or nicorandil
* Uncontrolled or newly diagnosed diabetes mellitus
* Symptomatic heart failure or heart failure requiring treatment with diuretics
* Fasting triglycerides \> 500mg/dL \[5.65mmol/L\]
* Patients with acute coronary syndromes, active peptic ulcer disease,
* Active gout,
* Standard exclusions for MRI will apply, i.e. pacemakers, implantable defibrillators, metal implants or embedded metallic fragments of any kind.
D: INCLUSION CRITERIA:

* Men \& women at least 40 years of age or older. Women must not be pregnant nor breast-feeding \& not planning to become pregnant or to breast-feed.
* History of IC of the lower extremities which has been present for at least 6 months with no change in symptoms in the previous 3 months prior to screening.
* LDL-C of \< 160 mg/dL and Triglycerides \< 800mg/dL.

EXCLUSION CRITERIA:

* Severe neuropathy
* Gross obesity (BMI ≥ 40)
* Presence of critical limb ischemia defined as ischemic rest pain, gangrene, ulceration, or pending amputation of a lower extremity due to severe PAD.
* Surgical intervention to alleviate symptoms of claudication within 6 months or endovascular interventions within 3 months
* Documented CAD taking any cholesterol-modifying agent
* Systolic blood pressure ≥ 160 mmHg \&/or diastolic blood pressure ≥ 95 mmHg
* Presence of clinically significant laboratory test abnormalities for liver or renal function tests or HgbA1C.
* History of alcohol abuse or currently drinks alcohol in excess.

Answer: D