The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries.

At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study.

Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a combination of these two drugs, is also approved by the FDA to treat high cholesterol. The use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve "intermittent claudication" (leg pain caused by narrowing of the arteries in the leg) is considered investigational. An investigational use is one that is not approved by the FDA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kos Pharmaceuticals
• Treatments: Dihydromevinolin; L 647318; Lovastatin; Niacin; Niacinamide; Nicotinic Acids

Criteria

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 <800.

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 and unable to undergo washout as judged by the Investigator or due to personal choice.

• Systolic blood pressure ≥160 mmHg &/or diastolic blood pressure ≥95 mmHg.

• Presence of clinically significant laboratory test abnormalities for liver or renal function tests, thyroid function or HgbA1C.

• History of alcohol abuse or currently drinks alcohol in excess.