Trial · NCT00822172
Evaluation of Cilostazol in Combination With L-Carnitine
NCT00822172, Phase 4, Completed, Colorado Prevention Center; results first posted 2013-05-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Cilostazol in Combination With L-Carnitine. Trials, record NCT00822172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00822172
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Cilostazol in Combination With L-Carnitine
- NCT number
- NCT00822172
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 164 participants, actual
- Lead sponsor
- Colorado Prevention Center
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Peripheral Arterial Disease
- Interventions
- Levocarnitine tartrate, cilostazol
- First posted
- 2009-01-14
- Last updated
- 2019-11-29
- Results first posted
- 2013-05-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Peak Walking Time (PWT) at Day 180 | Baseline, 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. |
| Secondary | Change From Baseline in Peak Walking Time at Day 180 | Baseline, 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. |
| Secondary | Change From Baseline in Peak Walking Time at Day 90 | Baseline, 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. |
| Secondary | Change From Baseline in Claudication Onset Time at Day 180 | Baseline, 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. |
| Secondary | Change From Baseline in Claudication Onset Time at Day 90 | Baseline, 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. |
| Secondary | Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 180 | Baseline, 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 |
| Secondary | Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 90 | Baseline, 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 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Peak Walking Time (PWT) at Day 180 | Baseline, Day 180 | modified Intent to Treat Population (mITT) | Log Minutes | MEAN |
| SECONDARY | Change From Baseline in Peak Walking Time at Day 180 | Baseline, Day 180 | Per Protocol (PP) Population | Log Minutes | MEAN |
| SECONDARY | Change From Baseline in Peak Walking Time at Day 90 | Baseline, Day 90 | modified Intent to Treat Population (mITT) | Log Minutes | MEAN |
| SECONDARY | Change From Baseline in Claudication Onset Time at Day 180 | Baseline, Day 180 | modified Intent to Treat Population (mITT) | Log Minutes | MEAN |
| SECONDARY | Change From Baseline in Claudication Onset Time at Day 90 | Baseline, Day 90 | modified Intent to Treat Population (mITT) | Log Minutes | MEAN |
| SECONDARY | Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 180 | Baseline, Day 180 | modified Intent to Treat Population (mITT) | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 90 | Baseline, Day 90 | modified Intent to Treat Population (mITT) | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Peak Walking Time (PWT) at Day 180 | Cilostazol + L-Carnitine | 0.241 | Standard Deviation 0.3836 | Log Minutes | |
| Change From Baseline in Peak Walking Time (PWT) at Day 180 | Cilostazol + Placebo | 0.134 | Standard Deviation 0.3343 | Log Minutes | |
| Change From Baseline in Peak Walking Time at Day 180 | Cilostazol + L-Carnitine | 0.267 | Standard Deviation 0.3516 | Log Minutes | |
| Change From Baseline in Peak Walking Time at Day 180 | Cilostazol + Placebo | 0.145 | Standard Deviation 0.3124 | Log Minutes | |
| Change From Baseline in Peak Walking Time at Day 90 | Cilostazol + L-Carnitine | 0.166 | Standard Deviation 0.3571 | Log Minutes | |
| Change From Baseline in Peak Walking Time at Day 90 | Cilostazol + Placebo | 0.139 | Standard Deviation 0.3293 | Log Minutes | |
| Change From Baseline in Claudication Onset Time at Day 180 | Cilostazol + L-Carnitine | 1.065 | Standard Deviation 0.6680 | Log Minutes | |
| Change From Baseline in Claudication Onset Time at Day 180 | Cilostazol + Placebo | 0.896 | Standard Deviation 0.7364 | Log Minutes | |
| Change From Baseline in Claudication Onset Time at Day 90 | Cilostazol + L-Carnitine | 1.001 | Standard Deviation 0.6476 | Log Minutes | |
| Change From Baseline in Claudication Onset Time at Day 90 | Cilostazol + Placebo | 0.815 | Standard Deviation 0.7000 | Log Minutes |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cilostazol + L-Carnitine | 80 | |
| Overall Study | STARTED | Cilostazol + Placebo | 83 | |
| Overall Study | COMPLETED | Cilostazol + L-Carnitine | 65 | |
| Overall Study | COMPLETED | Cilostazol + Placebo | 64 | |
| Overall Study | NOT COMPLETED | Cilostazol + L-Carnitine | 15 | |
| Overall Study | NOT COMPLETED | Cilostazol + Placebo | 19 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Cilostazol + L-Carnitine | 9 | 80 | 16 |
| other | Diarrhoea | Gastrointestinal disorders | Cilostazol + Placebo | 8 | 83 | 17 |
| other | Headache | Nervous system disorders | Cilostazol + L-Carnitine | 10 | 80 | 15 |
| other | Headache | Nervous system disorders | Cilostazol + Placebo | 14 | 83 | 17 |
| serious | Coronary artery disease | Cardiac disorders | Cilostazol + L-Carnitine | 1 | 80 | 1 |
| serious | Coronary artery disease | Cardiac disorders | Cilostazol + Placebo | 1 | 83 | 1 |
| serious | Prostate cancer | Renal and urinary disorders | Cilostazol + L-Carnitine | 0 | 80 | 0 |
| serious | Prostate cancer | Renal and urinary disorders | Cilostazol + Placebo | 1 | 83 | 1 |
| serious | Urosepsis | Renal and urinary disorders | Cilostazol + L-Carnitine | 0 | 80 | 0 |
| serious | Urosepsis | Renal and urinary disorders | Cilostazol + Placebo | 1 | 83 | 1 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilostazol + L-Carnitine | ||
| Total, all-cause mortality | Cilostazol + Placebo | ||
| Total, other adverse events | Cilostazol + L-Carnitine | 19 | 80 |
| Total, other adverse events | Cilostazol + Placebo | 22 | 83 |
| Total, serious adverse events | Cilostazol + L-Carnitine | 11 | 80 |
| Total, serious adverse events | Cilostazol + Placebo | 10 | 83 |
Source ClinicalTrials.gov
Papers34
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cilostazol + L-Carnitine vs Cilostazol + Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00822172
GET https://conductscience.org/api/trials/v1/NCT00822172/events?page=2