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

This study has been completed.
Sponsor:
Information provided by:
Kos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00071266
First received: October 16, 2003
Last updated: October 31, 2006
Last verified: October 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Intermittent Claudication
Peripheral Vascular Disease
 Drug: Niacin Extended Release and Lovastatin Tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - a Matrix Design

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kos Pharmaceuticals:
Estimated Enrollment: 870
Study Start Date: October 2003
Detailed Description:

This is a Phase 3, 32-week, double-blind, diet-intervention, randomized, parallel group, ten-arm, multi-center, multi-national, dose titration study evaluating the safety and efficacy of NL in patients with intermittent claudication (IC).

The objectives of this study are to evaluate the safety and efficacy of NL in patients with IC. The primary efficacy analysis will be the percent change from baseline in Peak Walking Time (PWT) calculated from the natural logarithm of the ratio of the time walked on treadmill at the Week 32 Visit divided by the time walked at baseline. Other efficacy measures will include Claudication Onset Time (COT) percent changes from baseline to Week 32 , changes in Ankle Brachial Index (ABI), Quality of Life (QoL) percent changes at Weeks 20 and 32, lower limb amputations, composite of cardiovascular events (MI, stroke, and vascular death), and coronary and peripheral artery revascularizations. Safety variables will include serum transaminases, routine chemistry parameters, hematology, and adverse events. Pharmacokinetic analyses will be conducted as well.

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071266

  Show 26 Study Locations
Sponsors and Collaborators
Kos Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00071266     History of Changes
Other Study ID Numbers: MA-03-010401, The TROPIC Study
Study First Received: October 16, 2003
Last Updated: October 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Kos Pharmaceuticals:
Intermittent Claudication
Peripheral Arterial Disease
Atherosclerosis
Niacin
 Lovastatin
PAD
IC

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Signs and Symptoms
Vascular Diseases
Lovastatin
 Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015