Efficacy Study of Oral L-Citrulline in Patients Taking Simvastatin With Peripheral Arterial Disease
Recruitment status was Active, not recruiting
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.
Peripheral Arterial Disease
Drug: L-citrulline tablets, 1000 mg
Drug: Placebo tablets matching L-citrulline tablets
Drug: Background simvastatin at a stable dose of 40 mg qHS
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Change in absolute claudication walking distance from baseline to end of 12-week double-blind treatment period.
- Change in pain-free walking distance
- Changes in QOL scores from baseline to 12 and 36 weeks
- Change in absolute claudication walking distance from baseline to 36 weeks
|Study Start Date:||March 2006|
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.
|Municipal Healthcare Institution, Gatchina Central District Hospital|
|Gatchina, Russia, Russian Federation, 188300|
|Russian State Medical University at Filatov City Hospital #15|
|Moscow, Russia, Russian Federation, 111539|
|Vishnevsky Institute of Surgery, Russian Medical Academy of Science|
|Moscow, Russia, Russian Federation, 113811|
|Municipal Prophylaxis and Treatment Institution, City Hospital #13|
|N. Novgorod, Russia, Russian Federation, 603018|
|Municipal Medical Institution City Hospital #1 of Saratov|
|Saratov, Russia, Russian Federation, 410056|
|St. Petersburg State Healthcare Institution, Research for Emergency Medical Care|
|St. Petersburg, Russia, Russian Federation, 192242|
|St. Petersburg State Healthcare Institution, Hospital #2|
|St. Petersburg, Russia, Russian Federation, 194354|
|State Educational Institution of Higher Professional Education|
|St. Petersburg, Russia, Russian Federation, 197089|
|St. Petersburg State Healthcare Institution, Pokrovskaya Hospital|
|St. Petersburg, Russia, Russian Federation, 199106|
|St. Petersburg State Healthcare Institution, Hospital #26|
|St. Petersburg, Russia, Russian Federation, 196247|
|Study Chair:||William Spickler, MD, PhD||Angiogenix|