Evaluation of Cilostazol in Combination With L-Carnitine (ECLECTIC)

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Colorado Prevention Center
ClinicalTrials.gov Identifier:
NCT00822172
First received: January 13, 2009
Last updated: April 11, 2013
Last verified: April 2013
Results First Received: March 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Conditions: Peripheral Vascular Disease
Intermittent Claudication
Peripheral Arterial Disease
Interventions: Dietary Supplement: Levocarnitine tartrate
Drug: cilostazol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first participant was randomized on September 19th, 2008 and the last subject was randomized on May 7, 2010. Clinical study sites were a mixture of university/hospital settings, VA hospitals, professional research centers and medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study included a cilostazol run in period. From the 164 participants who remained eligible at the end of the run in period, only 1 participant did not subsequently receive treatment. This was due to voluntary withdrawal by the participant.

Reporting Groups
  Description
Cilostazol + L-Carnitine

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.

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.

Cilostazol + Placebo

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.


Participant Flow:   Overall Study
    Cilostazol + L-Carnitine     Cilostazol + Placebo  
STARTED     80     83  
COMPLETED     65     64  
NOT COMPLETED     15     19  
Adverse Event                 10                 12  
Death                 1                 0  
Lost to Follow-up                 3                 1  
Withdrawal by Subject                 1                 4  
site closed                 0                 1  
unknown                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cilostazol + L-Carnitine

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.

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.

Cilostazol + Placebo

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.

Total Total of all reporting groups

Baseline Measures
    Cilostazol + L-Carnitine     Cilostazol + Placebo     Total  
Number of Participants  
[units: participants]
  80     83     163  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     43     27     70  
>=65 years     37     56     93  
Age  
[units: years]
Mean ± Standard Deviation
  65.8  ± 9.39     67.3  ± 8.00     66.5  ± 8.74  
Gender  
[units: participants]
     
Female     14     16     30  
Male     66     67     133  
Region of Enrollment  
[units: participants]
     
United States     80     83     163  



  Outcome Measures

1.  Primary:   The Effect of Cilostazol Combined With L-carnitine on Change in Peak Walking Time (PWT) Compared to Cilostazol Alone From Baseline/Day 0 to Day 180 in Subjects With Peripheral Artery Disease (PAD) Limited by Intermittent Claudication (IC).   [ Time Frame: Day 0 to Day 180 ]

2.  Primary:   Safety of Combining Cilostazol With L-carnitine by Evaluating Laboratory Abnormalities and Adverse Events (AEs).   [ Time Frame: Day 0 to Day 210 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   The Combination of Cilostazol and L-carnitine on PWT Compared to Cilostazol Alone From Baseline/Day 0 to Day 90 in Subjects With Peripheral Artery Disease (PAD) Limited by Intermittent Claudication (IC).   [ Time Frame: Day 0 to Day 90 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   The Effect of the Combination of Cilostazol and L-carnitine on Claudication Onset Time (COT) and Quality of Life (QOL), as Measured Using the Walking Impairment Questionnaire (WIQ) and SF-36v2® at Days 90 and 180.   [ Time Frame: Day 0 to Days 90 and 180 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: William Hiatt, MD, President
Organization: CPC Clinical Research
phone: 3038609900
e-mail: william.hiatt@cpcmed.org


Publications:
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
Rizza v, Lorefice R, Rizza N et al. Pharmacokinetics of L-Carnitine in Human Subjects. In: Ferrari R, DiMauro S, Sherwood G, eds. L-Carnitine and its Role in Medicine: From Function to Therapy. 1 ed San Diego: Academic Press, Inc., 1992:63-77.

Publications automatically indexed to this study:

Responsible Party: Colorado Prevention Center
ClinicalTrials.gov Identifier: NCT00822172     History of Changes
Other Study ID Numbers: CPC-08-01
Study First Received: January 13, 2009
Results First Received: March 1, 2013
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board