Evaluation of Cilostazol in Combination With L-Carnitine
NCT ID: NCT00822172
Last Updated: 2019-11-29
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
164 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-09-30
Study Completion Date
2010-12-31
Brief Summary
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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.
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Detailed Description
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Peripheral Artery Disease (PAD) is a narrowing of the blood vessels that supply the leg with blood. It is caused by atherosclerosis (hardening of the arteries).
Muscles require oxygen carried by the blood. When the leg muscles do not get enough blood and oxygen, this can cause pain, cramping, fatigue, and/or discomfort in the leg muscles during walking or exercise. These symptoms are called intermittent claudication (IC). In more severe cases, tissues do not get enough blood and oxygen at rest, and pain may also be present when the legs are resting. Peripheral Artery Disease (PAD)is one of the most common causes of pain and disability in people between 55 and 75 years of age.
Cilostazol is a medication currently available by prescription for intermittent claudication. L-carnitine is an over-the-counter supplement. It is a natural substance in the human body and is also in some red meats, nuts, and energy drinks.
Some subjects in the study will take L-carnitine with cilostazol and others will take placebo with cilostazol. 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 placebo is a tablet or pill that looks like regular medication, but it doesn't have any actual medicine in it. A second purpose of the study is to see if L-carnitine is absorbed into the blood stream.
Muscles require oxygen carried by the blood. When the leg muscles do not get enough blood and oxygen, this can cause pain, cramping, fatigue, and/or discomfort in the leg muscles during walking or exercise. These symptoms are called intermittent claudication (IC). In more severe cases, tissues do not get enough blood and oxygen at rest, and pain may also be present when the legs are resting. Peripheral Artery Disease (PAD)is one of the most common causes of pain and disability in people between 55 and 75 years of age.
Cilostazol is a medication currently available by prescription for intermittent claudication. L-carnitine is an over-the-counter supplement. It is a natural substance in the human body and is also in some red meats, nuts, and energy drinks.
Some subjects in the study will take L-carnitine with cilostazol and others will take placebo with cilostazol. 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 placebo is a tablet or pill that looks like regular medication, but it doesn't have any actual medicine in it. A second purpose of the study is to see if L-carnitine is absorbed into the blood stream.
Conditions
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Peripheral Vascular Disease
Intermittent Claudication
Peripheral Arterial Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Cilostazol + L-Carnitine
1 tablet cilostazol 100 mg PO BID and 3 capsules L-carnitine 334 mg PO BID
Group Type
ACTIVE_COMPARATOR
Levocarnitine tartrate
Intervention Type
DIETARY_SUPPLEMENT
Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.
cilostazol
Intervention Type
DRUG
Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days.
Cilostazol + Placebo
1 tablet cilostazol 100 mg PO BID and 3 capsules placebo PO BID
Group Type
PLACEBO_COMPARATOR
cilostazol
Intervention Type
DRUG
Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days.
Interventions
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Levocarnitine tartrate
Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.
Intervention Type
DIETARY_SUPPLEMENT
cilostazol
Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days.
Intervention Type
DRUG
Other Intervention Names
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Carnitine
L-carnitine
Levocarnitine
Pletal
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* The subject has a known or suspected allergy to the study medication(s) or class of study medication(s) (cilostazol or L-carnitine) to be administered.
* The subject has initiated an exercise training program within 3 months of Screening 1, has the inability to maintain his or her current level of physical activity throughout the study, or the subject plans on enrolling in an exercise training program during the study.
* The subject plans to change his/her smoking status during the planned duration of this study (subjects will be advised that stopping smoking is best for his/her health).
* The subject is currently pregnant or breastfeeding.
* The subject has received an investigational drug or biological agent within 30 days prior to Screening 1.
* The subject is currently participating in or plans to enroll in another clinical trial during this study.
* The subject has any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial.
* In the Investigator's opinion, the subject experienced any Adverse Events (AEs) during the tolerance phase of the Screening period that present a potential ongoing safety concern.
* 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.
* The subject has a known or suspected allergy to the study medication(s) or class of study medication(s) (cilostazol or L-carnitine) to be administered.
* The subject has initiated an exercise training program within 3 months of Screening 1, has the inability to maintain his or her current level of physical activity throughout the study, or the subject plans on enrolling in an exercise training program during the study.
* The subject plans to change his/her smoking status during the planned duration of this study (subjects will be advised that stopping smoking is best for his/her health).
* The subject is currently pregnant or breastfeeding.
* The subject has received an investigational drug or biological agent within 30 days prior to Screening 1.
* The subject is currently participating in or plans to enroll in another clinical trial during this study.
* The subject has any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial.
* In the Investigator's opinion, the subject experienced any Adverse Events (AEs) during the tolerance phase of the Screening period that present a potential ongoing safety concern.
Minimum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
Colorado Prevention Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Neil Goldenberg, MD, PhD
Role: STUDY_CHAIR
University of Colorado Heather Sciences Center
Locations
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Internal Medicine Physicians Associates
Phoenix, Arizona, United States
Site Status
Tatum Ridge Internal Medicine
Phoenix, Arizona, United States
Site Status
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
Site Status
VA Palo Alto Health Care System
Palo Alto, California, United States
Site Status
University of California at Davis Vascular Center
Sacramento, California, United States
Site Status
Sacramento Heart and Vascular Research Center
Sacramento, California, United States
Site Status
Apex Research Institute
Santa Ana, California, United States
Site Status
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Site Status
Aurora Denver Cardiology Associates
Denver, Colorado, United States
Site Status
Pensacola Research Consultants, Inc.
Pensacola, Florida, United States
Site Status
DMI Healthcare Group, Inc.
Pinellas Park, Florida, United States
Site Status
Meridian Research
St. Petersburg, Florida, United States
Site Status
Ochsner Medical Center
New Orleans, Louisiana, United States
Site Status
HPV Heart, PA
Columbia, Maryland, United States
Site Status
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
Site Status
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Site Status
University of Rochester Medical Center
Rochester, New York, United States
Site Status
Durham VA-Medical Center
Durham, North Carolina, United States
Site Status
Radiant Research, Inc
Columbus, Ohio, United States
Site Status
Jobst Vascular Center
Toledo, Ohio, United States
Site Status
Peripheral Vascular Associates
San Antonio, Texas, United States
Site Status
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Site Status
Radiant Research- Salt Lake City
Salt Lake City, Utah, United States
Site Status
Beloit Clinic Research Office
Beloit, Wisconsin, United States
Site Status
Countries
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United States
References
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Hiatt WR. Carnitine and peripheral arterial disease. Ann N Y Acad Sci. 2004 Nov;1033:92-8. doi: 10.1196/annals.1320.008.
Reference Type
BACKGROUND
Hiatt WR, Nawaz D, Brass EP. Carnitine metabolism during exercise in patients with peripheral vascular disease. J Appl Physiol (1985). 1987 Jun;62(6):2383-7. doi: 10.1152/jappl.1987.62.6.2383.
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Hiatt WR. Management of Intermittent Claudication. Contemporary Diagnosis and management of Peripheral arterial Disease. 1 ed. Newtown: Handvbooks in Healthcare Co., Inc., 2004:51-9
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Rowlands TE, Donnelly R. Medical therapy for intermittent claudication. Eur J Vasc Endovasc Surg. 2007 Sep;34(3):314-21. doi: 10.1016/j.ejvs.2007.04.001. Epub 2007 May 29.
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Dawson DL, Cutler BS, Meissner MH, Strandness DE Jr. Cilostazol has beneficial effects in treatment of intermittent claudication: results from a multicenter, randomized, prospective, double-blind trial. Circulation. 1998 Aug 18;98(7):678-86. doi: 10.1161/01.cir.98.7.678.
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BACKGROUND
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Beebe HG, Dawson DL, Cutler BS, Herd JA, Strandness DE Jr, Bortey EB, Forbes WP. A new pharmacological treatment for intermittent claudication: results of a randomized, multicenter trial. Arch Intern Med. 1999 Sep 27;159(17):2041-50. doi: 10.1001/archinte.159.17.2041.
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BACKGROUND
Dawson DL, Cutler BS, Hiatt WR, Hobson RW 2nd, Martin JD, Bortey EB, Forbes WP, Strandness DE Jr. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med. 2000 Nov;109(7):523-30. doi: 10.1016/s0002-9343(00)00569-6.
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BACKGROUND
Strandness DE Jr, Dalman RL, Panian S, Rendell MS, Comp PC, Zhang P, Forbes WP. Effect of cilostazol in patients with intermittent claudication: a randomized, double-blind, placebo-controlled study. Vasc Endovascular Surg. 2002 Mar-Apr;36(2):83-91. doi: 10.1177/153857440203600202.
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Thompson PD, Zimet R, Forbes WP, Zhang P. Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication. Am J Cardiol. 2002 Dec 15;90(12):1314-9. doi: 10.1016/s0002-9149(02)02869-2.
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Pratt CM. Analysis of the cilostazol safety database. Am J Cardiol. 2001 Jun 28;87(12A):28D-33D. doi: 10.1016/s0002-9149(01)01719-2.
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Hiatt WR, Money SR, Brass EP. Long-term safety of cilostazol in patients with peripheral artery disease: the CASTLE study (Cilostazol: A Study in Long-term Effects). J Vasc Surg. 2008 Feb;47(2):330-336. doi: 10.1016/j.jvs.2007.10.009. Epub 2007 Dec 26.
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Hiatt WR, Regensteiner JG, Creager MA, Hirsch AT, Cooke JP, Olin JW, Gorbunov GN, Isner J, Lukjanov YV, Tsitsiashvili MS, Zabelskaya TF, Amato A. Propionyl-L-carnitine improves exercise performance and functional status in patients with claudication. Am J Med. 2001 Jun 1;110(8):616-22. doi: 10.1016/s0002-9343(01)00704-5.
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Brass EP, Anthony R, Cobb FR, Koda I, Jiao J, Hiatt WR. The novel phosphodiesterase inhibitor NM-702 improves claudication-limited exercise performance in patients with peripheral arterial disease. J Am Coll Cardiol. 2006 Dec 19;48(12):2539-45. doi: 10.1016/j.jacc.2006.07.064. Epub 2006 Nov 28.
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Bauer TA, Brass EP, Barstow TJ, Hiatt WR. Skeletal muscle StO2 kinetics are slowed during low work rate calf exercise in peripheral arterial disease. Eur J Appl Physiol. 2007 May;100(2):143-51. doi: 10.1007/s00421-007-0412-0. Epub 2007 Feb 20.
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Brass EP, Hiatt WR, Gardner AW, Hoppel CL. Decreased NADH dehydrogenase and ubiquinol-cytochrome c oxidoreductase in peripheral arterial disease. Am J Physiol Heart Circ Physiol. 2001 Feb;280(2):H603-9. doi: 10.1152/ajpheart.2001.280.2.H603.
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Eder K, Felgner J, Becker K, Kluge H. Free and total carnitine concentrations in pig plasma after oral ingestion of various L-carnitine compounds. Int J Vitam Nutr Res. 2005 Jan;75(1):3-9. doi: 10.1024/0300-9831.75.1.3.
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Giamberardino MA, Dragani L, Valente R, Di Lisa F, Saggini R, Vecchiet L. Effects of prolonged L-carnitine administration on delayed muscle pain and CK release after eccentric effort. Int J Sports Med. 1996 Jul;17(5):320-4. doi: 10.1055/s-2007-972854.
Reference Type
BACKGROUND
Volek JS, Kraemer WJ, Rubin MR, Gomez AL, Ratamess NA, Gaynor P. L-Carnitine L-tartrate supplementation favorably affects markers of recovery from exercise stress. Am J Physiol Endocrinol Metab. 2002 Feb;282(2):E474-82. doi: 10.1152/ajpendo.00277.2001.
Reference Type
BACKGROUND
Kraemer WJ, Volek JS, French DN, Rubin MR, Sharman MJ, Gomez AL, Ratamess NA, Newton RU, Jemiolo B, Craig BW, Hakkinen K. The effects of L-carnitine L-tartrate supplementation on hormonal responses to resistance exercise and recovery. J Strength Cond Res. 2003 Aug;17(3):455-62. doi: 10.1519/1533-4287(2003)0172.0.co;2.
Reference Type
BACKGROUND
Spiering BA, Kraemer WJ, Vingren JL, Hatfield DL, Fragala MS, Ho JY, Maresh CM, Anderson JM, Volek JS. Responses of criterion variables to different supplemental doses of L-carnitine L-tartrate. J Strength Cond Res. 2007 Feb;21(1):259-64. doi: 10.1519/00124278-200702000-00046.
Reference Type
BACKGROUND
Brevetti G, Chiariello M, Ferulano G, Policicchio A, Nevola E, Rossini A, Attisano T, Ambrosio G, Siliprandi N, Angelini C. Increases in walking distance in patients with peripheral vascular disease treated with L-carnitine: a double-blind, cross-over study. Circulation. 1988 Apr;77(4):767-73. doi: 10.1161/01.cir.77.4.767.
Reference Type
BACKGROUND
Brevetti G, Perna S, Sabba C, Rossini A, Scotto di Uccio V, Berardi E, Godi L. Superiority of L-propionylcarnitine vs L-carnitine in improving walking capacity in patients with peripheral vascular disease: an acute, intravenous, double-blind, cross-over study. Eur Heart J. 1992 Feb;13(2):251-5. doi: 10.1093/oxfordjournals.eurheartj.a060155.
Reference Type
BACKGROUND
Brevetti G, Diehm C, Lambert D. European multicenter study on propionyl-L-carnitine in intermittent claudication. J Am Coll Cardiol. 1999 Nov 1;34(5):1618-24. doi: 10.1016/s0735-1097(99)00373-3.
Reference Type
BACKGROUND
Goldenberg NA, Krantz MJ, Hiatt WR. L-Carnitine plus cilostazol versus cilostazol alone for the treatment of claudication in patients with peripheral artery disease: a multicenter, randomized, double-blind, placebo-controlled trial. Vasc Med. 2012 Jun;17(3):145-54. doi: 10.1177/1358863X12442264.
Reference Type
DERIVED
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Other Identifiers
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CPC-08-01
Identifier Type: -
Identifier Source: org_study_id
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