NCT00351286

Efficacy Study of Oral L-Citrulline in Patients Taking Simvastatin With Peripheral Arterial Disease

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral L-Citrulline Compared to Placebo in Patients Taking Background Simvastatin 40 mg qD and With Peripheral Arterial Disease Including Intermittent Claudication

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (planned)
• Sponsor: Angiogenix · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To prove the combination of L-citrulline with simvastatin leads to greater improvement in the symptoms of peripheral arterial disease (PAD) than simvastatin alone by evaluating oral L- citrulline or placebo against simvastatin for improvement in treadmill walking distance in patients, 40-75 years of age, who have PAD with intermittent claudication.

Detailed description

The primary objective of this study is to prove the combination of L-citrulline with simvastatin leads to greater improvement in the symptoms of PAD than simvastatin alone. This will be accomplished by evaluating efficacy of orally administered L-citrulline or placebo against background therapy with simvastatin for improvement in treadmill absolute claudication walking distance (ACWD) in patients, 40-75 years of age, who have PAD with intermittent claudication in Fontaine stage II and symptom-limited treadmill walking distance. Secondary objectives include comparing the combination therapy to simvastatin alone for improvement in treadmill pain-free walking distance (PFWD) and ischemic window. Other secondary objectives include evaluating the safety and tolerability of L-citrulline alone or combined with simvastatin in this patient population and assessing the effects of treatment on quality of life (QOL) as measured by two QOL instruments.

Conditions

• Peripheral Arterial Disease
• Intermittent Claudication

Interventions

Type	Name	Description
DRUG	L-citrulline tablets, 1000 mg
DRUG	Placebo tablets matching L-citrulline tablets
DRUG	Background simvastatin at a stable dose of 40 mg qHS

Timeline

• Start date: 2006-03-01
• First posted: 2006-07-12
• Last updated: 2006-10-18

Locations

10 sites across 1 country: Russia