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TROPIC: Niacin ER/Lovastatin Dose Response in Intermittent Claudication

NCT00071266Phase 3

Key facts

Status: Completed
Start: Oct 2003
Countries: 1
Sponsor: Kos Pharmaceuticals, Inc.
Modality: Orthosteric Ligands, Metabolically Activated Prodrugs

Drugs: simvastatin + extended-release niacin
Conditions: intermittent claudication (IC)

Overview

Phase 3, randomised, double-blind trial of simvastatin + extended-release niacin in intermittent claudication (IC) (3 arms), sponsored by Kos Pharmaceuticals, Inc. Primary endpoint: Peak Walking Time at 32 weeks. Started Oct 2003; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Niacin ER/Lovastatin Combination
Various doses of Niacin ER and Lovastatin in combination (Advicor)
Niacin ER Monotherapy
Various doses of Niacin ER (Niaspan)
Lovastatin Monotherapy
Various doses of Lovastatin (Mevacor)

Who it enrols

Patients aged 40+ with intermittent claudication for at least 6 months, LDL-C < 160 mg/dL, and Triglycerides < 800 mg/dL. Excludes severe neuropathy, gross obesity (BMI >= 40), critical limb ischemia, recent surgery, and uncontrolled hypertension.

Endpoints

Primary

Peak Walking Time32 weeks

Secondary

Claudication Onset Time32 weeks
Ankle Brachial Index32 weeks
Quality of Life32 weeks
Lower Limb Amputations32 weeks
Composite of Cardiovascular Events32 weeks
Coronary and Peripheral Artery Revascularizations32 weeks

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