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Sponsored by: |
Angiogenix |
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Information provided by: | Angiogenix |
ClinicalTrials.gov Identifier: | NCT00351286 |
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.
Condition | Intervention | 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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 160 |
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.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Russian Federation, Russia | |
State Educational Institution of Higher Professional Education | |
St. Petersburg, Russia, Russian Federation, 197089 | |
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 | |
St. Petersburg State Healthcare Institution, Research for Emergency Medical Care | |
St. Petersburg, Russia, Russian Federation, 192242 | |
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 | |
Russian State Medical University at Filatov City Hospital #15 | |
Moscow, Russia, Russian Federation, 111539 | |
Municipal Healthcare Institution, Gatchina Central District Hospital | |
Gatchina, Russia, Russian Federation, 188300 | |
St. Petersburg State Healthcare Institution, Pokrovskaya Hospital | |
St. Petersburg, Russia, Russian Federation, 199106 | |
Municipal Medical Institution City Hospital #1 of Saratov | |
Saratov, Russia, Russian Federation, 410056 |
Study Chair: | William Spickler, MD, PhD | Angiogenix |
Study ID Numbers: | ANGX-1039-02 |
Study First Received: | July 10, 2006 |
Last Updated: | October 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00351286 |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation |
peripheral arterial disease peripheral vascular disease claudication |
Arterial Occlusive Diseases Signs and Symptoms Peripheral Vascular Diseases Simvastatin |
Vascular Diseases Intermittent Claudication Arteriosclerosis |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |