Overview
Efficacy Study of Oral L-Citrulline in Patients Taking Simvastatin With Peripheral Arterial Disease
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AngiogenixTreatments:
SimvastatinCriteria
Inclusion Criteria:1. Male or female, 40-75 years of age
2. If female, post-menopausal for the past year, surgically sterile (i.e., tubal
ligation, hysterectomy), or using an adequate method of birth control (i.e., oral
contraceptives, double barrier method, IUD cover, sterilized partner, or other method
deemed appropriate by Investigator)
3. If male capable of fathering children, using an adequate method of birth control
(i.e., condom or partner using adequate method of birth control)
4. Peripheral arterial disease with stable, reproducible, intermittent claudication and
symptom-limited treadmill walking distance of at least 6 months duration
5. Rest ankle-brachial index (ABI) ≤0.90 and 10 mm Hg decrease in ankle pressure 1 minute
after completing the ETT
6. ACWD on a standardized (Skinner-Gardner protocol) ETT ≥50 m (164 feet) but ≤300 m (984
feet) determined by the average result on two consecutive ETTs performed at least 7
days apart during the screening phase (Fontaine stage II)
7. ACWD variability <25% between two consecutive ETTs performed at least 7 days apart
during the screening phase. The percent variability is calculated by the difference of
the two walking distances divided by the greater of the two walking distances
multiplied by 100%. If the variability exceeds 25% a third ETT may be performed and
the variability between the second and third test used to determine baseline and
inclusion criteria
8. Willingness to receive dietary counseling and follow a low-cholesterol diet during the
study
9. Ability to give written informed consent and has signed a written informed consent
form approved by the Investigator's Independent Ethics Committee (IEC)
Exclusion Criteria:
1. Critical limb ischemia (defined as presence of rest pain requiring analgesics for more
than 2 weeks or the presence of lower limb ulcers or gangrene)
2. Coronary artery or peripheral artery angioplasty or surgical limb arterial bypass
within the last 3 months
3. Any previous amputation on the lower limbs
4. Anticipated requirement of surgical or percutaneous revascularization within 3 months
of randomization
5. Currently participating in a supervised exercise regimen
6. Stroke, myocardial infarction, or deep-vein thrombosis within the last 3 months
7. Non-atherosclerotic PAD (e.g., thromboangiitis obliterans)
8. Known abdominal aortic aneurysm ≥4.5 cm
9. Unstable angina pectoris within the last 3 months
10. Congestive heart failure (New York Heart Association Class III or IV) despite
treatment
11. Severe, uncontrolled hypertension (sitting systolic blood pressure >180 mm Hg or
sitting diastolic blood pressure >95 mm Hg)
12. Anemia (hemoglobin <10 g/dL in women and 11 g/dL in men) or any clinically significant
bleeding episode within the last year
13. Abnormal platelet count (platelets >150,000/mm3 or <60,000/mm3)
14. Type I diabetes mellitus or Type II diabetes mellitus if it is accompanied by diabetic
peripheral neuropathy
15. Morbid obesity (body mass index >40 kg/m2)
16. Severe renal insufficiency (creatinine >221 µmol/L (2.5 mg/dL))
17. Severe hepatic insufficiency (ALT [SGPT] and AST [SGOT] ≥ 3x upper limit of normal on
two separate tests
18. Any disorder that would affect the interpretation of ETT results
19. Use of medications that are not allowed and which cannot be discontinued during the
study
20. Participation in an investigational drug or device study within previous 30 days
21. Underlying disease other than PAD resulting in a life expectancy of less than 1 year
22. If female, breast feeding, pregnancy confirmed by a positive serum pregnancy test, or
using inadequate birth control
23. Other conditions that could impair informed consent or compliance