Please select the arm or intervention descriptions that belong 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: Arm Label: 1; Type: OTHER; Interventions: Drug: ER niacin/laropiprant | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Comparator : placebo (unspecified) | Intervention Type: DRUG; Name: ER niacin/laropiprant; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Comparator : placebo (unspecified); Assigned to Arm(s): 2
B: Arm Label: Part 1 - Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Comparator: ezetimibe/simvastatin + niacin (ER) | Arm Label: Part 1 -Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Comparator: ezetimibe (+) simvastatin, Drug: Comparator: Placebo to Niacin (ER) | Arm Label: Part 1 - Arm 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Comparator: Placebo to ezetimibe/simvastatin, Drug: Comparator: niacin (ER) tablet | Arm Label: Part 2 - Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Comparator: ezetimibe/simvastatin and niacin (ER) | Arm Label: Part 2 - Arm 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Comparator: ezetimibe and simvastatin, Drug: Comparator: Placebo to niacin (ER) | Intervention Type: DRUG; Name: Comparator: ezetimibe/simvastatin + niacin (ER); Assigned to Arm(s): Part 1 - Arm 1 | Intervention Type: DRUG; Name: Comparator: Placebo to ezetimibe/simvastatin; Assigned to Arm(s): Part 1 - Arm 3 | Intervention Type: DRUG; Name: Comparator: niacin (ER) tablet; Assigned to Arm(s): Part 1 - Arm 3 | Intervention Type: DRUG; Name: Comparator: ezetimibe (+) simvastatin; Assigned to Arm(s): Part 1 -Arm 2 | Intervention Type: DRUG; Name: Comparator: Placebo to Niacin (ER); Assigned to Arm(s): Part 1 -Arm 2 | Intervention Type: DRUG; Name: Comparator: ezetimibe/simvastatin and niacin (ER); Assigned to Arm(s): Part 2 - Arm 1 | Intervention Type: DRUG; Name: Comparator: ezetimibe and simvastatin; Assigned to Arm(s): Part 2 - Arm 2 | Intervention Type: DRUG; Name: Comparator: Placebo to niacin (ER); Assigned to Arm(s): Part 2 - Arm 2
C: Intervention Type: DRUG; Name: Niaspan; Assigned to Arm(s): N/A
D: Intervention Type: DRUG; Name: Niacin Extended Release and Lovastatin Tablets; Assigned to Arm(s): N/A

Answer: D