Trial · NCT01674712
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
NCT01674712, Phase 3, Completed, Abbott; results first posted 2014-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease. Trials, record NCT01674712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01674712
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
- NCT number
- NCT01674712
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 575 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Dyslipidemia
- Interventions
- Fixed Combination of Fenofibrate/simvastatin 145/20 mg, Simvastatin 20 mg, Fenofibrate 145 mg, Fixed Combination of Fenofibrate/simvastatin 145/40 mg, Simvastatin 40 mg
- First posted
- 2012-08-29
- Last updated
- 2014-12-11
- Other registries' IDs
- eudract:2011-005924-16
- Results first posted
- 2014-10-30
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Change of TG (Triglyceride) | from baseline to 12 weeks of treatment | Collection and measurement of blood samples. |
| Primary | Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol) | from baseline to 12 weeks of treatment | Collection and measurement of blood samples. |
| Primary | Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol) | from baseline to 12 weeks of treatment | Collection and measurement of blood samples. |
| Secondary | Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline | 12 weeks | Collection and measurement of blood samples |
| Secondary | Percentage of TC (Triglyceride) From Baseline | 12 weeks | Collection and measurement of blood samples |
| Secondary | Percentage of Apolipoprotein AI From Baseline | 12 weeks | Collection and measurement of blood samples |
| Secondary | Percentage of Apolipoprotein B From Baseline | 12 weeks | Collection and measurement of blood samples |
| Secondary | Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline | 12 weeks | Collection and measurement of blood samples |
| Secondary | Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk) | 12 weeks | Collection and measurement of blood samples |
| Secondary | Adverse Events | 12 weeks | Collection and measurement of blood samples |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Change of TG (Triglyceride) | from baseline to 12 weeks of treatment | The Primary Analysis was done for the sample set of patients with 12 weeks' assessment. | percentage of change | MEAN |
| PRIMARY | Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol) | from baseline to 12 weeks of treatment | The Primary Analysis was done for the sample set of patients with 12 weeks' assessment. | percentage of change | MEAN |
| PRIMARY | Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol) | from baseline to 12 weeks of treatment | The Primary Analysis was done for the sample set of patients with 12 weeks' assessment. | percentage of change | MEAN |
| SECONDARY | Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline | 12 weeks | |||
| SECONDARY | Percentage of TC (Triglyceride) From Baseline | 12 weeks | |||
| SECONDARY | Percentage of Apolipoprotein AI From Baseline | 12 weeks | |||
| SECONDARY | Percentage of Apolipoprotein B From Baseline | 12 weeks | |||
| SECONDARY | Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline | 12 weeks | |||
| SECONDARY | Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk) | 12 weeks | |||
| SECONDARY | Adverse Events | 12 weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Change of TG (Triglyceride) | Fenofibrate/Simvastatin 145/20 mg | -30.6 | Standard Deviation 25.8 | percentage of change | |
| Percentage of Change of TG (Triglyceride) | Simvastatin 20 mg | 10.7 | Standard Deviation 48.8 | percentage of change | |
| Percentage of Change of TG (Triglyceride) | Fenofibrate/Simvastatin 145/40 mg | -27.3 | Standard Deviation 35.9 | percentage of change | |
| Percentage of Change of TG (Triglyceride) | Simvastatin 40 mg | -2.9 | Standard Deviation 34.3 | percentage of change | |
| Percentage of Change of TG (Triglyceride) | Fenofibrate 145 mg | -21.6 | Standard Deviation 34.2 | percentage of change | |
| Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol) | Fenofibrate/Simvastatin 145/20 mg | 9.0 | Standard Deviation 16.8 | percentage of change | |
| Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol) | Simvastatin 20 mg | 0.3 | Standard Deviation 12.1 | percentage of change | |
| Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol) | Fenofibrate/Simvastatin 145/40 mg | 8.8 | Standard Deviation 16.5 | percentage of change | |
| Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol) | Simvastatin 40 mg | 2.2 | Standard Deviation 12.5 | percentage of change | |
| Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol) | Fenofibrate 145 mg | 7.6 | Standard Deviation 15.7 | percentage of change |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fenofibrate/Simvastatin 145/20 mg | 114 | |
| Overall Study | STARTED | Simvastatin 20 mg | 117 | |
| Overall Study | STARTED | Fenofibrate/Simvastatin 145/40 mg | 115 | |
| Overall Study | STARTED | Simvastatin 40 mg | 116 | |
| Overall Study | STARTED | Fenofibrate 145 mg | 113 | |
| Overall Study | Full Analysis Subject Sample | Fenofibrate/Simvastatin 145/20 mg | 109 | |
| Overall Study | Full Analysis Subject Sample | Simvastatin 20 mg | 114 | |
| Overall Study | Full Analysis Subject Sample | Fenofibrate/Simvastatin 145/40 mg | 110 | |
| Overall Study | Full Analysis Subject Sample | Simvastatin 40 mg | 112 | |
| Overall Study | Full Analysis Subject Sample | Fenofibrate 145 mg | 111 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events110
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 | Fenofibrate/Simvastatin 145/20 mg | 1 | 111 | |
| other | DIARRHOEA | Gastrointestinal disorders | Simvastatin 20 mg | 2 | 117 | |
| other | DIARRHOEA | Gastrointestinal disorders | Fenofibrate/Simvastatin 145/40 mg | 2 | 113 | |
| other | DIARRHOEA | Gastrointestinal disorders | Simvastatin 40 mg | 0 | 115 | |
| other | DIARRHOEA | Gastrointestinal disorders | Fenofibrate 145 mg | 5 | 112 | |
| other | NASOPHARYNGITIS | Infections and infestations | Fenofibrate/Simvastatin 145/20 mg | 1 | 111 | |
| other | NASOPHARYNGITIS | Infections and infestations | Simvastatin 20 mg | 0 | 117 | |
| other | NASOPHARYNGITIS | Infections and infestations | Fenofibrate/Simvastatin 145/40 mg | 1 | 113 | |
| other | NASOPHARYNGITIS | Infections and infestations | Simvastatin 40 mg | 3 | 115 | |
| other | NASOPHARYNGITIS | Infections and infestations | Fenofibrate 145 mg | 3 | 112 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fenofibrate/Simvastatin 145/20 mg | ||
| Total, all-cause mortality | Simvastatin 20 mg | ||
| Total, all-cause mortality | Fenofibrate/Simvastatin 145/40 mg | ||
| Total, all-cause mortality | Simvastatin 40 mg | ||
| Total, all-cause mortality | Fenofibrate 145 mg | ||
| Total, other adverse events | Fenofibrate/Simvastatin 145/20 mg | 8 | 111 |
| Total, other adverse events | Simvastatin 20 mg | 7 | 117 |
| Total, other adverse events | Fenofibrate/Simvastatin 145/40 mg | 4 | 113 |
| Total, other adverse events | Simvastatin 40 mg | 9 | 115 |
| Total, other adverse events | Fenofibrate 145 mg | 15 | 112 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT01674712
GET https://conductscience.org/api/trials/v1/NCT01674712/flow?page=2