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

Primary Purpose

Intermittent Claudication, Peripheral Vascular Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Niacin Extended Release and Lovastatin Tablets
Sponsored by
Kos Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring Intermittent Claudication, Peripheral Arterial Disease, Atherosclerosis, Niacin, Lovastatin, PAD, IC

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tatum Ridge Internal Medicine
  • Scottsdale Cardiovascular Research Institute, LLC
  • VA Palo Alto Health Care System
  • University of California-Davis; Department of Surgery
  • Sacramento Heart & Vascular Medical Associates
  • Clinical Research Center of California
  • North County Internal Medicine
  • University of Colorado Health Sciences Center
  • University of Connecticut Health Center
  • Cardiovascular Center of Sarasota
  • Clinical Research Center of Georgia
  • River Cities Cardiology, MPC
  • HPV Heart P.A.
  • St. Joseph Mercy-Oakland Research Office
  • Saint Louis University
  • Carolina Pharmaceutical Research
  • COR Clinical Research
  • New Hope Research of Oregon
  • Penn State College of Medicine
  • Radiant Research
  • Mainline Health Heart Center
  • Clinical Cardiology Research Center
  • Baylor College of Medicine
  • Pro Research Group, LLC
  • Hampton Roads Center for Clinical Research, Inc.
  • Care Foundation, Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 16, 2003
Last Updated
October 31, 2006
Sponsor
Kos Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00071266
Brief Title
The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
Official Title
The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - a Matrix Design
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kos Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Peripheral Vascular Disease
Keywords
Intermittent Claudication, Peripheral Arterial Disease, Atherosclerosis, Niacin, Lovastatin, PAD, IC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
870 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Niacin Extended Release and Lovastatin Tablets

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Tatum Ridge Internal Medicine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Scottsdale Cardiovascular Research Institute, LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California-Davis; Department of Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Sacramento Heart & Vascular Medical Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Clinical Research Center of California
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
North County Internal Medicine
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80200
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Clinical Research Center of Georgia
City
Warner Robins
State/Province
Georgia
ZIP/Postal Code
31093
Country
United States
Facility Name
River Cities Cardiology, MPC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
HPV Heart P.A.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
St. Joseph Mercy-Oakland Research Office
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Carolina Pharmaceutical Research
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
COR Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
New Hope Research of Oregon
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Radiant Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Mainline Health Heart Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Clinical Cardiology Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pro Research Group, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Hampton Roads Center for Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Care Foundation, Inc
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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