Efficacy Study of Oral L-Citrulline in Patients Taking Simvastatin With Peripheral Arterial Disease
NCT00351286 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2006-10-18
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.
Conditions
- Peripheral Arterial Disease
- Intermittent Claudication
Interventions
- DRUG
-
L-citrulline tablets, 1000 mg
- DRUG
-
Placebo tablets matching L-citrulline tablets
- DRUG
-
Background simvastatin at a stable dose of 40 mg qHS
Sponsors & Collaborators
-
Angiogenix
lead INDUSTRY
Principal Investigators
-
William Spickler, MD, PhD · Angiogenix
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
Countries
- Russia
Study Locations
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