Efficacy Study of Oral L-Citrulline in Patients Taking Simvastatin With Peripheral Arterial Disease
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|ClinicalTrials.gov Identifier: NCT00351286|
Recruitment Status : Unknown
Verified July 2006 by Angiogenix.
Recruitment status was: Active, not recruiting
First Posted : July 12, 2006
Last Update Posted : October 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Intermittent Claudication||Drug: L-citrulline tablets, 1000 mg Drug: Placebo tablets matching L-citrulline tablets Drug: Background simvastatin at a stable dose of 40 mg qHS||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351286
|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|
|St. Petersburg State Healthcare Institution, Hospital #26|
|St. Petersburg, Russia, Russian Federation, 196247|
|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|
|Study Chair:||William Spickler, MD, PhD||Angiogenix|