Trial · NCT01462877
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
NCT01462877, Phase 4, Completed, Abbott; results first posted 2015-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic. Trials, record NCT01462877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01462877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
- NCT number
- NCT01462877
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 506 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia
- Interventions
- fenofibrate
- First posted
- 2011-11-01
- Last updated
- 2015-03-17
- Results first posted
- 2015-02-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Triglyceride (TG) Change | Baseline and up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum Total Cholesterol | Baseline and up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum Low-density Lipoprotein Cholesterol | Baseline up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum High-density Lipoprotein Cholesterol | Baseline up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum Non-high-density Lipoprotein Cholesterol | Baseline up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum Apolipoprotein A1 | Baseline up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum Apolipoprotein B | Baseline up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum Alanine Aminotransferase | Baseline up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum Aspartate Aminotransferase | Baseline up to 8 weeks after intervention | Blood tests |
| Secondary | Change in Serum Creatine Kinase | Baseline up to 8 weeks after intervention | Blood tests |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Triglyceride (TG) Change | Baseline and up to 8 weeks after intervention | Full Analysis Set | percentage of TG change | MEAN |
| SECONDARY | Change in Serum Total Cholesterol | Baseline and up to 8 weeks after intervention | Full analysis set | percentage of TC change | MEAN |
| SECONDARY | Change in Serum Low-density Lipoprotein Cholesterol | Baseline up to 8 weeks after intervention | Full analysis set | percentage of LDL-C change | MEAN |
| SECONDARY | Change in Serum High-density Lipoprotein Cholesterol | Baseline up to 8 weeks after intervention | Full analysis set | percentage of HDL-C change | MEAN |
| SECONDARY | Change in Serum Non-high-density Lipoprotein Cholesterol | Baseline up to 8 weeks after intervention | Full analysis set | percentage of Non-HDL-C change | MEAN |
| SECONDARY | Change in Serum Apolipoprotein A1 | Baseline up to 8 weeks after intervention | Full analysis set | percentage of apoA1 change | MEAN |
| SECONDARY | Change in Serum Apolipoprotein B | Baseline up to 8 weeks after intervention | Full analysis set | percentage of apoB change | MEAN |
| SECONDARY | Change in Serum Alanine Aminotransferase | Baseline up to 8 weeks after intervention | Safety set | percentage of ALT change | MEDIAN |
| SECONDARY | Change in Serum Aspartate Aminotransferase | Baseline up to 8 weeks after intervention | Safety set | percentage of AST change | MEDIAN |
| SECONDARY | Change in Serum Creatine Kinase | Baseline up to 8 weeks after intervention | Safety set | percentage of CK change | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Triglyceride (TG) Change | Fenofibrate Arm | -38.12 | Standard Deviation 33.92 | percentage of TG change | |
| Change in Serum Total Cholesterol | Fenofibrate Arm | 2.75 | Standard Deviation 24.75 | percentage of TC change | |
| Change in Serum Low-density Lipoprotein Cholesterol | Fenofibrate Arm | 14.91 | Standard Deviation 39.80 | percentage of LDL-C change | |
| Change in Serum High-density Lipoprotein Cholesterol | Fenofibrate Arm | 17.40 | Standard Deviation 32.62 | percentage of HDL-C change | |
| Change in Serum Non-high-density Lipoprotein Cholesterol | Fenofibrate Arm | -1.30 | Standard Deviation 28.26 | percentage of Non-HDL-C change | |
| Change in Serum Apolipoprotein A1 | Fenofibrate Arm | 12.41 | Standard Deviation 28.74 | percentage of apoA1 change | |
| Change in Serum Apolipoprotein B | Fenofibrate Arm | 2.42 | Standard Deviation 50.48 | percentage of apoB change | |
| Change in Serum Alanine Aminotransferase | Fenofibrate Arm | 0.00 | Full Range -72.92 to 1118.75 | percentage of ALT change | |
| Change in Serum Aspartate Aminotransferase | Fenofibrate Arm | 10.91 | Full Range -77.73 to 676.47 | percentage of AST change | |
| Change in Serum Creatine Kinase | Fenofibrate Arm | 8.02 | Full Range -73.94 to 1429.63 | percentage of CK change |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fenofibrate Arm | 506 | |
| Overall Study | Safety Set | Fenofibrate Arm | 492 | |
| Overall Study | Full Analysis Set | Fenofibrate Arm | 468 | |
| Overall Study | Per-protocol Set | Fenofibrate Arm | 364 | |
| Overall Study | COMPLETED | Fenofibrate Arm | 435 | |
| Overall Study | NOT COMPLETED | Fenofibrate Arm | 71 |
Source ClinicalTrials.gov
Adverse events11
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 | Nausea | Gastrointestinal disorders | Fenofibrate Arm | 5 | 492 | 5 |
| other | Alanine aminotransferase increased | Investigations | Fenofibrate Arm | 6 | 492 | 6 |
| other | Aspartate aminotransferase increased | Investigations | Fenofibrate Arm | 6 | 492 | 6 |
| other | Blood creatine phosphokinase increased | Investigations | Fenofibrate Arm | 6 | 492 | 6 |
| serious | Hepatic enzyme increased | Hepatobiliary disorders | Fenofibrate Arm | 1 | 492 | 1 |
| serious | Angina unstable | Cardiac disorders | Fenofibrate Arm | 1 | 492 | 1 |
| serious | Myocardial infarction | Cardiac disorders | Fenofibrate Arm | 1 | 492 | 1 |
| serious | Coronary artery disease | Cardiac disorders | Fenofibrate Arm | 1 | 492 | 1 |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Fenofibrate Arm | 1 | 492 | 1 |
| serious | Herpes zoster | Infections and infestations | Fenofibrate Arm | 1 | 492 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fenofibrate Arm | ||
| Total, other adverse events | Fenofibrate Arm | 23 | 492 |
| Total, serious adverse events | Fenofibrate Arm | 7 | 492 |
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 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/NCT01462877
GET https://conductscience.org/api/trials/v1/NCT01462877/registered