Trial · NCT00914316
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities
NCT00914316, Not applicable, Terminated, Corewell Health East; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities. Trials, record NCT00914316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00914316
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities
- NCT number
- NCT00914316
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 29 participants, actual
- Lead sponsor
- Corewell Health East
- Conditions
- Peripheral Arterial Disease
- Interventions
- Ranolazine, Placebo
- First posted
- 2009-06-04
- Last updated
- 2017-08-09
- Results first posted
- 2017-08-09
- Limitations and caveats
- Early termination due to recruitment and retention difficulties, leading to small numbers of subjects. Missing data for several subjects.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Increase in Absolute Walking Distance Following Phase 1 | 12 weeks | Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test |
| Secondary | Percentage Increase in Absolute Walking Distance Following Phase 2 | 24 weeks | Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Increase in Absolute Walking Distance Following Phase 1 | 12 weeks | Missing data for 12 week test in 1 subject in Ranolazine/Ranolazine group, 1 subject in Ranolazine/placebo group, and 3 subjects in placebo/placebo group | percentage of baseline | MEDIAN |
| SECONDARY | Percentage Increase in Absolute Walking Distance Following Phase 2 | 24 weeks | Missing data from one subject 24 week treadmill test in placebo/placebo group | percentage of baeline | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Increase in Absolute Walking Distance Following Phase 1 | Phase 1-Ranolazine, Phase 2-Ranolazine | 112 | Inter-Quartile Range 112 to 112 | percentage of baseline | |
| Percentage Increase in Absolute Walking Distance Following Phase 1 | Phase 1 -Ranolazine, Phase 2 -Placebo | 108 | Inter-Quartile Range 105 to 121 | percentage of baseline | |
| Percentage Increase in Absolute Walking Distance Following Phase 1 | Phase 1 -Placebo, Phase 2 -Ranolazine | 145 | Inter-Quartile Range 127 to 216 | percentage of baseline | |
| Percentage Increase in Absolute Walking Distance Following Phase 1 | Phase 1 -Placebo, Phase 2 -Placebo | 155 | Inter-Quartile Range 142 to 166 | percentage of baseline | |
| Percentage Increase in Absolute Walking Distance Following Phase 2 | Phase 1-Ranolazine, Phase 2-Ranolazine | 98 | Inter-Quartile Range 98 to 98 | percentage of baeline | |
| Percentage Increase in Absolute Walking Distance Following Phase 2 | Phase 1 -Ranolazine, Phase 2 -Placebo | 120 | Inter-Quartile Range 107 to 131 | percentage of baeline | |
| Percentage Increase in Absolute Walking Distance Following Phase 2 | Phase 1 -Placebo, Phase 2 -Ranolazine | 181 | Inter-Quartile Range 163 to 200 | percentage of baeline | |
| Percentage Increase in Absolute Walking Distance Following Phase 2 | Phase 1 -Placebo, Phase 2 -Placebo | 145 | Inter-Quartile Range 121 to 148 | percentage of baeline |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Phase 1-Ranolazine, Phase 2-Ranolazine | 7 | |
| Phase 1 | STARTED | Phase 1 -Ranolazine, Phase 2 -Placebo | 6 | |
| Phase 1 | STARTED | Phase 1 -Placebo, Phase 2 -Ranolazine | 8 | |
| Phase 1 | STARTED | Phase 1 -Placebo, Phase 2 -Placebo | 8 | |
| Phase 1 | COMPLETED | Phase 1-Ranolazine, Phase 2-Ranolazine | 2 | |
| Phase 1 | COMPLETED | Phase 1 -Ranolazine, Phase 2 -Placebo | 4 | |
| Phase 1 | COMPLETED | Phase 1 -Placebo, Phase 2 -Ranolazine | 3 | |
| Phase 1 | COMPLETED | Phase 1 -Placebo, Phase 2 -Placebo | 6 | |
| Phase 1 | NOT COMPLETED | Phase 1-Ranolazine, Phase 2-Ranolazine | 5 | |
| Phase 1 | NOT COMPLETED | Phase 1 -Ranolazine, Phase 2 -Placebo | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events4
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 |
|---|---|---|---|---|---|---|
| serious | myocardial infarction | Cardiac disorders | Phase 1-Ranolazine, Phase 2-Ranolazine | 1 | 3 | 1 |
| serious | myocardial infarction | Cardiac disorders | Phase 1 -Ranolazine, Phase 2 -Placebo | 0 | 5 | 0 |
| serious | myocardial infarction | Cardiac disorders | Phase 1 -Placebo, Phase 2 -Ranolazine | 0 | 4 | 0 |
| serious | myocardial infarction | Cardiac disorders | Phase 1 -Placebo, Phase 2 -Placebo | 0 | 8 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1-Ranolazine, Phase 2-Ranolazine | 0 | 3 |
| Total, all-cause mortality | Phase 1 -Ranolazine, Phase 2 -Placebo | 0 | 5 |
| Total, all-cause mortality | Phase 1 -Placebo, Phase 2 -Ranolazine | 0 | 4 |
| Total, all-cause mortality | Phase 1 -Placebo, Phase 2 -Placebo | 0 | 8 |
| Total, other adverse events | Phase 1-Ranolazine, Phase 2-Ranolazine | 0 | 3 |
| Total, other adverse events | Phase 1 -Ranolazine, Phase 2 -Placebo | 0 | 5 |
| Total, other adverse events | Phase 1 -Placebo, Phase 2 -Ranolazine | 0 | 4 |
| Total, other adverse events | Phase 1 -Placebo, Phase 2 -Placebo | 0 | 8 |
| Total, serious adverse events | Phase 1-Ranolazine, Phase 2-Ranolazine | 1 | 3 |
| Total, serious adverse events | Phase 1 -Ranolazine, Phase 2 -Placebo | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00914316
GET https://conductscience.org/api/trials/v1/NCT00914316/flow?page=2