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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00351286 on ClinicalTrials.gov