Evaluation of Cilostazol in Combination With L-Carnitine

Completed · Phase 4 · Has a placebo group

Conditions studied: Peripheral Vascular Disease, Intermittent Claudication, Peripheral Arterial Disease

In brief

The purpose of this study is to see how safe and effective L carnitine taken with cilostazol is compared to placebo taken with cilostazol for people with intermittent claudication. A second purpose of the study is to see if L-carnitine is absorbed into the blood stream.

Key facts

Study ID

NCT00822172

Run by

Colorado Prevention Center

People needed

164

Starts

2008-09-01

Expected to finish

2010-12-01

Last updated by the study team

2019-11-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is >40 years old.
• The subject has a diagnosis of Intermittent Claudication (IC) due to Peripheral Artery Disease (PAD).
• Ankle brachial index (ABI) < 0.90 in at least one extremity, or if Ankle brachial index (ABI)is ≥ 0.90 to ≤ 1.0, a reduction of at least 20% in Ankle brachial index (ABI), in at least one extremity, when measured within 1 minute after claudication-limiting treadmill testing. If the subject has non-compressible arteries then a toe brachial index (TBI) < 0.70 is required in at least one extremity.
• Symptoms of Intermittent Claudication (IC)must be stable for at least 3 months prior to Screening 1.
• Peak Walking Time (PWT) of ≥ 1 to ≤ 12 minutes on a Gardner protocol at Screening 2.
• If the subject is currently on statin therapy, they need to have been on statin therapy for at least 3 months prior to Screening 1. Subjects who have recently discontinued statin therapy must "wash-out" for at least one month prior to Screening 1.
• Tolerance to background therapy of cilostazol (approximately 2 weeks of 50 mg by mouth (PO) twice daily (BID), approximately 1 week of 100 mg PO BID) between Screening 2 and Baseline Visit.
• Subjects must be either male or females that are post-menopausal, surgically incapable of bearing children or if they are of childbearing potential must have a negative serum pregnancy test at Screening 1 and a negative urine pregnancy test at Day 0 and must agree to use double-barrier contraceptive methods until the end of investigational therapy (Day 180 Visit).
• The subject is able to comply with scheduled visits, treatment plan and laboratory tests.
• The subject is willing to participate in this study as documented by written informed consent.
• During the tolerance phase of the Screening period, the subject demonstrates at least 70% compliance with cilostazol and is willing to continue treatment.

You may not qualify if…

• Evidence of critical limb ischemia (CLI) (e.g., ischemic rest pain or ischemic ulceration).
• The subject has had a major amputation of the leg or any other amputation that limits walking ability.
• The subject has diabetes mellitus type 1 or poorly controlled diabetes mellitus type 2 (hemoglobin A1c (HbA1c) > 10).
• The subject has had a transient ischemic attack (TIA) or deep vein thrombosis in the last 3 months.
• The subject has had a stroke within the last 6 months.
• The subject has participated in an angiogenic gene therapy study, unless known to be given placebo.
• The subject has any of the following laboratory parameters at Screening 1:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin >3 times the upper limit of normal (ULN)
• Serum creatinine >2.5 mg/dL
• Hemoglobin (Hb) <10 g/dL
• White blood cell (WBC) count <3.0 x 103/µL; or > 15 x 103/µL
• Platelet count <100 x 103/µL
• The subject walks less than 1 minute at 2 miles per hour (mph), 0% grade as determined during the Screening 1 treadmill familiarization.
• The subject has clinically significant electrocardiogram (ECG) abnormalities at rest or changes during exercise or post-exercise at Screening 2 or Day 0.
• The subject has any history or clinical evidence of congestive heart failure (CHF), with which the clinician-investigator concurs.
• The subject has uncontrolled hypertension (resting blood pressure (BP) > 180/100 mmHg) or uncontrolled arrhythmic disorders at Screening 1.
• History of coronary or peripheral revascularization within 6 months prior to Screening 1.
• The subject plans to undergo coronary or peripheral revascularization during the course of the study.
• The subject is currently taking L-carnitine or medication for claudication (including pentoxifylline or cilostazol). In this situation, the subject would become eligible for Screening 1 after a 6 week washout of the medication.
• Subjects currently taking or those who anticipate taking ketoconazole, itraconazole, or erythromycin. The subject would become eligible for Screening 1 immediately after completion of therapy or discontinuation of the drug(s).
• The subject has a known, active malignancy that requires active anti-neoplastic therapy. (stable basal cell skin cancer allowed. Cancer being treated soley with hormonal therapy is allowed.)
• The subject has a severe co-morbidity with an expected survival of less than 2 years.
• The subject's Peak Walking Time (PWT) is limited by symptoms other than claudication (e.g., shortness of breath (SOB), fatigue, angina, arthritis, etc.). If, in the opinion of the investigator, the subject were to improve their Peak Walking Time (PWT) from study therapy to the extent that his or her walking would then be limited by a symptom other than claudication, the subject should not be enrolled.
• The subject has a history of alcohol or other substance abuse within 6 months of Screening 1.
• The subject has an inability to tolerate oral medication administration.

Where it is running

• Internal Medicine Physicians Associates — Phoenix, Arizona, United States
• Tatum Ridge Internal Medicine — Phoenix, Arizona, United States
• Central Arkansas Veteran's Healthcare System — Little Rock, Arkansas, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• University of California at Davis Vascular Center — Sacramento, California, United States
• Sacramento Heart and Vascular Research Center — Sacramento, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Aurora Denver Cardiology Associates — Aurora, Colorado, United States
• Aurora Denver Cardiology Associates — Denver, Colorado, United States
• Pensacola Research Consultants, Inc. — Pensacola, Florida, United States
• DMI Healthcare Group, Inc. — Pinellas Park, Florida, United States
• Meridian Research — St. Petersburg, Florida, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• HPV Heart, PA — Columbia, Maryland, United States
• University of Massachusetts Medical Center — Worcester, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Durham VA-Medical Center — Durham, North Carolina, United States
• Radiant Research, Inc — Columbus, Ohio, United States
• Jobst Vascular Center — Toledo, Ohio, United States
• Peripheral Vascular Associates — San Antonio, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Radiant Research- Salt Lake City — Salt Lake City, Utah, United States
• Beloit Clinic Research Office — Beloit, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.