Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication
Information source: Kos Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intermittent Claudication; Peripheral Vascular Disease
Intervention: Niacin Extended Release and Lovastatin Tablets (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Kos Pharmaceuticals
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.
Clinical Details
Official title: Effect of Niacin ER/Lovastatin on Peak Walking Time and Claudication Onset Time in Patients With Intermittent Claudication
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Detailed description:
This is a Phase 3, 28-week, double-blind, diet-intervention, randomized, parallel group,
three-arm, multi-center, dose-titration study.
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) and Claudication Onset Time (COT), calculated as the logarithm of the quotient of
the time walked on treadmill at a visit divided by the time walked at baseline. Other
efficacy measures will include Ankle Brachial Index (ABI), QoL measurements, composite of
cardiovascular events (MI, stroke, vascular death, and lower limb amputations), and coronary
and peripheral artery revascularization procedures. Safety variables will include serum
transaminases, routine chemistry parameters, hematology, and AEs. Pharmacokinetic analyses
will be conducted as well.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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 < 800mg/dL.
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
- 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.
Locations and Contacts
Additional Information
Starting date: January 2003
Ending date: March 2006
Last updated: October 31, 2006
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