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Peripheral Vascular DiseasePhase 4ECLECTICNCT00822172

Evaluation of Cilostazol in Combination With L-Carnitine

A Phase 4 study testing Levocarnitine tartrate and cilostazol in people with Peripheral Vascular Disease and Intermittent Claudication, run by Colorado Prevention Center at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Levocarnitine tartrate and cilostazol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
24 sitesUnited States
Study dates
Sep 2008to Dec 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 33Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012

  • Beloit Clinic Research Office

    Beloit, Wisconsin, 53511

  • HPV Heart, PA

    Columbia, Maryland, 21044

  • Radiant Research, Inc

    Columbus, Ohio, 43212

  • Aurora Denver Cardiology Associates

    Denver, Colorado, 80218

  • Durham VA-Medical Center

    Durham, North Carolina, 27705

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Central Arkansas Veteran's Healthcare System

    Little Rock, Arkansas, 72205

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Pensacola Research Consultants, Inc.

    Pensacola, Florida, 32504

  • Internal Medicine Physicians Associates

    Phoenix, Arizona, 85006

  • Tatum Ridge Internal Medicine

    Phoenix, Arizona, 85032

  • DMI Healthcare Group, Inc.

    Pinellas Park, Florida, 33782

  • University of Rochester Medical Center

    Rochester, New York, 14623

  • University of California at Davis Vascular Center

    Sacramento, California, 95817

  • Sacramento Heart and Vascular Research Center

    Sacramento, California, 95825

  • Radiant Research- Salt Lake City

    Salt Lake City, Utah, 84107

  • Peripheral Vascular Associates

    San Antonio, Texas, 78205

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Apex Research Institute

    Santa Ana, California, 92705

  • Meridian Research

    St. Petersburg, Florida, 33709

  • Jobst Vascular Center

    Toledo, Ohio, 43606

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Evaluation of Cilostazol in Combination With L-Carnitine in Subjects With Intermittent Claudication

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.

Read the detailed description

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.

Being tested
Levocarnitine tartrate, cilostazol
Keywords
Peripheral Vascular Disease, Peripheral Arterial Disease, Intermittent Claudication, Peak Walking Time, Claudication Onset Time, Cilostazol, Carnitine
Medical subject headings
Peripheral Vascular Diseases, Intermittent Claudication, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levocarnitine tartrateDietary supplement

    Also called Carnitine, L-carnitine, Levocarnitine

    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.

  • cilostazolDrug

    Also called Pletal

    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.

Study groups in NCT00822172
Study groupRoleWhat they receive
Cilostazol + L-CarnitineActive comparator1 tablet cilostazol 100 mg PO BID and 3 capsules L-carnitine 334 mg PO BID
Receives: Dietary Supplement: Levocarnitine tartrate; Drug: cilostazol
Cilostazol + PlaceboPlacebo comparator1 tablet cilostazol 100 mg PO BID and 3 capsules placebo PO BID
Receives: Drug: cilostazol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Peak Walking Time (PWT) at Day 180

    Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. This maximum time walked is referred to as the peak walking time (PWT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.

    Measured: Baseline, Day 180

Secondary outcomes (6)

  1. Change From Baseline in Peak Walking Time at Day 180

    Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. This maximum time walked is referred to as the peak walking time (PWT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.

    Measured: Baseline, Day 180

  2. Change From Baseline in Peak Walking Time at Day 90

    Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. This maximum time walked is referred to as the peak walking time (PWT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.

    Measured: Baseline, Day 90

  3. Change From Baseline in Claudication Onset Time at Day 180

    Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. The time during the conduct of the exercise treadmill test at which the subject first reported claudication symptoms is referred to as the claudication onset time (COT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.

    Measured: Baseline, Day 180

  4. Change From Baseline in Claudication Onset Time at Day 90

    Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. The time during the conduct of the exercise treadmill test at which the subject first reported claudication symptoms is referred to as the claudication onset time (COT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.

    Measured: Baseline, Day 90

  5. Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 180

    Subjects completed the Walking Impairment Questionnaire (WIQ) whereby they were asked about their maximal walking distance before having to rest as a result of claudication symptoms associated with their peripheral artery disease (PAD). The WIQ was administered at the Baseline, Day 90, and Day 180 visits. On the WIQ subjects were asked a series of questions related to their degree of physical difficulty that best described how hard it was for the subject to walk on level ground without stopping to rest. The questions began by asking the degree of difficulty walking around indoors, then 50 feet, 150 feet, 300 feet, 600 feet, 900 feet, and lastly 1500 feet. The responses range from None (best outcome) to Slight, then Some, then Much, then lastly Unable (worst outcome). The walking distance score was calculated from the 7 questions in the section by way of a weighted sum. A score of 100 indicated no walking impairment. A score of 0 corresponded to the highest degree of walking impairment

    Measured: Baseline, Day 180

  6. Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 90

    Subjects completed the Walking Impairment Questionnaire (WIQ) whereby they were asked about their maximal walking distance before having to rest as a result of claudication symptoms associated with their peripheral artery disease (PAD). The WIQ was administered at the Baseline, Day 90, and Day 180 visits. On the WIQ subjects were asked a series of questions related to their degree of physical difficulty that best described how hard it was for the subject to walk on level ground without stopping to rest. The questions began by asking the degree of difficulty walking around indoors, then 50 feet, 150 feet, 300 feet, 600 feet, 900 feet, and lastly 1500 feet. The responses range from None (best outcome) to Slight, then Some, then Much, then lastly Unable (worst outcome). The walking distance score was calculated from the 7 questions in the section by way of a weighted sum. A score of 100 indicated no walking impairment. A score of 0 corresponded to the highest degree of walking impairment

    Measured: Baseline, Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00822172
Sponsor's protocol ID
CPC-08-01
Acronym
ECLECTIC
Status last verified
Nov 2019
First submitted
13 Jan 2009
Last updated
29 Nov 2019
Data monitoring committee
No

Publications

  • Hiatt WR. Carnitine and peripheral arterial disease. Ann N Y Acad Sci. 2004 Nov;1033:92-8. doi: 10.1196/annals.1320.008.

    PubMed 15591006

  • 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.

    PubMed 3610932

  • 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

  • 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.

    PubMed 17532651

  • 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.

    PubMed 9715861

  • Money SR, Herd JA, Isaacsohn JL, Davidson M, Cutler B, Heckman J, Forbes WP. Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease. J Vasc Surg. 1998 Feb;27(2):267-74; discussion 274-5. doi: 10.1016/s0741-5214(98)70357-x.

    PubMed 9510281

  • Elam MB, Heckman J, Crouse JR, Hunninghake DB, Herd JA, Davidson M, Gordon IL, Bortey EB, Forbes WP. Effect of the novel antiplatelet agent cilostazol on plasma lipoproteins in patients with intermittent claudication. Arterioscler Thromb Vasc Biol. 1998 Dec;18(12):1942-7. doi: 10.1161/01.atv.18.12.1942.

    PubMed 9848888

  • 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.

    PubMed 10510990

  • 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.

    PubMed 11063952

  • 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.

    PubMed 11951094

  • Regensteiner JG, Ware JE Jr, McCarthy WJ, Zhang P, Forbes WP, Heckman J, Hiatt WR. Effect of cilostazol on treadmill walking, community-based walking ability, and health-related quality of life in patients with intermittent claudication due to peripheral arterial disease: meta-analysis of six randomized controlled trials. J Am Geriatr Soc. 2002 Dec;50(12):1939-46. doi: 10.1046/j.1532-5415.2002.50604.x.

    PubMed 12473004

  • 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.

    PubMed 12480040

  • 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.

    PubMed 11434897

  • 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.

    PubMed 18155871

  • 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.

    PubMed 11382369

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levocarnitine tartrate and cilostazol in people with Peripheral Vascular Disease and Intermittent Claudication, run by Colorado Prevention Center at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Peak Walking Time (PWT) at Day 180 (time frame: Baseline, Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00822172, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.

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