Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication
2 other identifiers
interventional
366
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2003
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 9, 2003
CompletedFirst Posted
Study publicly available on registry
June 12, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedNovember 1, 2006
October 1, 2006
June 9, 2003
October 31, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hiatt WR, Hirsch AT, Creager MA, Rajagopalan S, Mohler ER, Ballantyne CM, Regensteiner JG, Treat-Jacobson D, Dale RA, Rooke T. Effect of niacin ER/lovastatin on claudication symptoms in patients with peripheral artery disease. Vasc Med. 2010 Jun;15(3):171-9. doi: 10.1177/1358863X09360579. Epub 2010 Mar 8.
PMID: 20212073DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 9, 2003
First Posted
June 12, 2003
Study Start
January 1, 2003
Study Completion
March 1, 2006
Last Updated
November 1, 2006
Record last verified: 2006-10