Trial · NCT02455336
Fenofibrate Treatment in SCI
NCT02455336, Phase 2, Phase 3, Completed, VA Office of Research and Development; results first posted 2019-06-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fenofibrate Treatment in SCI. Trials, record NCT02455336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02455336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fenofibrate Treatment in SCI
- NCT number
- NCT02455336
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 23 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Spinal Cord Injury, Dyslipidemia
- Interventions
- Fenofibrate, No intervention
- First posted
- 2015-05-27
- Last updated
- 2019-06-26
- Results first posted
- 2019-06-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Triglyceride Concentration (Percent Change From Baseline) | two months from initiating drug treatment | To determine the efficacy of fenofibrate monotherapy after 2 months of treatment to improve the lipoprotein profile; a successful response will be defined as a 25% reduction in the serum TG concentration at 2 months. |
| Secondary | Triglyceride Concentration (Percent Change From Baseline) | four months from initiating drug treatment | To determine the efficacy of fenofibrate monotherapy to lower TG concentration at 4 months of treatment, when the peak therapeutic efficacy to drug treatment has been reported to occur. |
| Other | Adverse Event Profile | 4 months | Documentation and description of adverse events will be obtained in subjects who have received drug treatment compared to events occurring in the control group. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Triglyceride Concentration (Percent Change From Baseline) | two months from initiating drug treatment | percent change from baseline | MEAN | |
| SECONDARY | Triglyceride Concentration (Percent Change From Baseline) | four months from initiating drug treatment | percent change from baseline | MEAN | |
| OTHER_PRE_SPECIFIED | Adverse Event Profile | 4 months | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Triglyceride Concentration (Percent Change From Baseline) | Fenofibrate | -40 | Standard Deviation 12 | percent change from baseline | |
| Triglyceride Concentration (Percent Change From Baseline) | No Intervention | -2 | Standard Deviation 16 | percent change from baseline | |
| Triglyceride Concentration (Percent Change From Baseline) | Fenofibrate | -40 | Standard Deviation 20 | percent change from baseline | |
| Triglyceride Concentration (Percent Change From Baseline) | No Intervention | 7 | Standard Deviation 14 | percent change from baseline | |
| Adverse Event Profile | Fenofibrate | Elevated liver enzymes | 2 | Participants | |
| Adverse Event Profile | No Intervention | Elevated liver enzymes | 0 | Participants | |
| Adverse Event Profile | Fenofibrate | Gastrointestinal discomfort | 2 | Participants | |
| Adverse Event Profile | No Intervention | Gastrointestinal discomfort | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fenofibrate | 15 | |
| Overall Study | STARTED | No Intervention | 8 | |
| Overall Study | COMPLETED | Fenofibrate | 10 | |
| Overall Study | COMPLETED | No Intervention | 6 | |
| Overall Study | NOT COMPLETED | Fenofibrate | 5 | |
| Overall Study | NOT COMPLETED | No Intervention | 2 |
Source ClinicalTrials.gov
Adverse 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 |
|---|---|---|---|---|---|---|
| other | Elevated liver enzymes | Hepatobiliary disorders | Fenofibrate | 2 | 15 | 2 |
| other | Elevated liver enzymes | Hepatobiliary disorders | No Intervention | 0 | 8 | 0 |
| other | Gastrointestinal discomfort | Gastrointestinal disorders | Fenofibrate | 2 | 15 | 2 |
| other | Gastrointestinal discomfort | Gastrointestinal disorders | No Intervention | 0 | 8 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fenofibrate | 0 | 15 |
| Total, all-cause mortality | No Intervention | 0 | 8 |
| Total, other adverse events | Fenofibrate | 2 | 15 |
| Total, other adverse events | No Intervention | 0 | 8 |
| Total, serious adverse events | Fenofibrate | 0 | 15 |
| Total, serious adverse events | No Intervention | 0 | 8 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fenofibrate vs No Intervention: deaths from any cause | Trial comparisons |
| Fenofibrate vs No Intervention: serious adverse events | 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/NCT02455336
GET https://conductscience.org/api/trials/v1/NCT02455336/registered