Trial · NCT00504829
Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
NCT00504829, Phase 2, Completed, Asahi Kasei Therapeutics, Inc.; results first posted 2020-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia. Trials, record NCT00504829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00504829
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
- NCT number
- NCT00504829
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 220 participants, actual
- Lead sponsor
- Asahi Kasei Therapeutics, Inc.
- Conditions
- Dyslipidemia
- Interventions
- LCP-AtorFen, atorvastatin, fenofibrate
- First posted
- 2007-07-20
- Last updated
- 2020-02-17
- Results first posted
- 2020-02-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | baseline(randomization) to 12 weeks | Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet. |
| Secondary | Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | baseline (week 0) to 12 weeks | Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy |
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 | Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | baseline(randomization) to 12 weeks | Modified intent-to-treat population consisted of all subjects randomized who had at least one dose of study drug and one post-baseline (randomization) assessment | percent change from baseline | MEAN |
| SECONDARY | Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | baseline (week 0) to 12 weeks | Modified intent-to-treat population consisted of all subjects randomized who had at least one dose of study drug and one post-baseline (randomization) assessment | percent change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | LCP-AtorFen 40/100mg | non-HDL | -44.8 | Standard Deviation 16.2 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | Atorvastatin 40mg | non-HDL | -40.2 | Standard Deviation 17.3 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | LCP-AtorFen 40/100mg | triglycerides | -49.1 | Standard Deviation 24.46 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | Atorvastatin 40mg | triglycerides | -28.9 | Standard Deviation 32.25 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | LCP-AtorFen 40/100mg | HDL | 19.7 | Standard Deviation 21.38 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy | Atorvastatin 40mg | HDL | 6.5 | Standard Deviation 18.77 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | LCP-AtorFen 40/100mg | non-HDL | -44.8 | Standard Deviation 16.2 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | Fenofibrate 145mg | non-HDL | -16.1 | Standard Deviation 17.5 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | LCP-AtorFen 40/100mg | LDL | -42.3 | Standard Deviation 20.01 | percent change from baseline |
| Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy | Fenofibrate 145mg | LDL | -13.9 | Standard Deviation 18.31 | percent change from baseline |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCP-AtorFen 40/100mg | 73 | |
| Overall Study | STARTED | Atorvastatin 40mg | 74 | |
| Overall Study | STARTED | Fenofibrate 145mg | 73 | |
| Overall Study | COMPLETED | LCP-AtorFen 40/100mg | 67 | |
| Overall Study | COMPLETED | Atorvastatin 40mg | 70 | |
| Overall Study | COMPLETED | Fenofibrate 145mg | 63 | |
| Overall Study | NOT COMPLETED | LCP-AtorFen 40/100mg | 6 | |
| Overall Study | NOT COMPLETED | Atorvastatin 40mg | 4 | |
| Overall Study | NOT COMPLETED | Fenofibrate 145mg | 10 |
Source ClinicalTrials.gov
Adverse events159
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 | Endocrine Disorders (any) | Endocrine disorders | LCP-AtorFen 40/100mg | 0 | 73 | |
| other | Endocrine Disorders (any) | Endocrine disorders | Atorvastatin 40mg | 2 | 74 | |
| other | Endocrine Disorders (any) | Endocrine disorders | Fenofibrate 145mg | 0 | 73 | |
| other | Gastrointestinal Disorders (any) | Gastrointestinal disorders | LCP-AtorFen 40/100mg | 13 | 73 | |
| other | Gastrointestinal Disorders (any) | Gastrointestinal disorders | Atorvastatin 40mg | 9 | 74 | |
| other | Gastrointestinal Disorders (any) | Gastrointestinal disorders | Fenofibrate 145mg | 10 | 73 | |
| other | Abdominal distension | Gastrointestinal disorders | LCP-AtorFen 40/100mg | 2 | 73 | |
| other | Abdominal distension | Gastrointestinal disorders | Atorvastatin 40mg | 2 | 74 | |
| other | Abdominal distension | Gastrointestinal disorders | Fenofibrate 145mg | 0 | 73 | |
| other | Constipation | Gastrointestinal disorders | LCP-AtorFen 40/100mg | 3 | 73 |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCP-AtorFen 40/100mg | ||
| Total, all-cause mortality | Atorvastatin 40mg | ||
| Total, all-cause mortality | Fenofibrate 145mg | ||
| Total, other adverse events | LCP-AtorFen 40/100mg | 43 | 73 |
| Total, other adverse events | Atorvastatin 40mg | 49 | 74 |
| Total, other adverse events | Fenofibrate 145mg | 48 | 73 |
| Total, serious adverse events | LCP-AtorFen 40/100mg | 1 | 73 |
| Total, serious adverse events | Atorvastatin 40mg | 0 | 74 |
| Total, serious adverse events | Fenofibrate 145mg | 2 | 73 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20110022 | DERIVED |
Source PubMed
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/NCT00504829
GET https://conductscience.org/api/trials/v1/NCT00504829/events?page=2