Trial · NCT00359281
Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents
NCT00359281, Phase 2, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2014-03-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents. Trials, record NCT00359281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00359281
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents
- NCT number
- NCT00359281
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Healthy
- Interventions
- atorvastatin, simvastatin, ezetimibe, fenofibrate, dextromethorphan, Extended Release Niacin
- First posted
- 2006-08-02
- Last updated
- 2018-02-23
- Results first posted
- 2014-03-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg) | 0 to 24 hour | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg) |
| Primary | AUC0-t Simvastatin | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin |
| Primary | AUC0-t Simvastatin Acid | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid |
| Primary | AUC0-t Total Ezetimibe | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe |
| Primary | AUC0-t Rosuvastatin (Lomitapide 10 mg) | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg) |
| Primary | AUC0-t Fenofibric Acid | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid |
| Primary | AUC0-t Atorvastatin Acid (Lomitapide 60 mg) | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg) |
| Primary | AUC0-t Rosuvastatin (Lomitapide 60 mg) | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg) |
| Primary | AUC0-t Nicotinic Acid | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid |
| Primary | AUC0-t Nicotinuric Acid | 0 to 24 hours | Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg) | 0 to 24 hour | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline to Day 8 | Intention To Treat | Percent Change | MEAN |
| PRIMARY | AUC0-t Simvastatin | 0 to 24 hours | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t Simvastatin Acid | 0 to 24 hours | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t Total Ezetimibe | 0 to 24 hours | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t Rosuvastatin (Lomitapide 10 mg) | 0 to 24 hours | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t Fenofibric Acid | 0 to 24 hours | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t Atorvastatin Acid (Lomitapide 60 mg) | 0 to 24 hours | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t Rosuvastatin (Lomitapide 60 mg) | 0 to 24 hours | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t Nicotinic Acid | 0 to 24 hours | Pharmacokinetic | Ratio | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg) | Atorvastatin 20 mg + Lomitapide 10 mg | 110.97 | 90% Confidence Interval 98.42 to 125.12 | Ratio | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Atorvastatin 20 mg + Lomitapide 10 mg | -30.99 | Standard Deviation 14.47 | Percent Change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Simvastatin 20 mg + Lomitapide 10 mg | -26.43 | Standard Deviation 17.77 | Percent Change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Ezetimibe 10 mg + Lomitapide 10 mg | -28.36 | Standard Deviation 12.53 | Percent Change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Rosuvastatin 20 mg + Lomitapide 10 mg | -41.74 | Standard Deviation 10.37 | Percent Change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Fenofibrate 145 mg + Lomitapide 10 mg | -20.12 | Standard Deviation 25.56 | Percent Change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Atorvastatin 20 mg + Lomitapide 60 mg | -66.02 | Standard Deviation 15.18 | Percent Change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Rosuvastatin 20 mg + Lomitapide 60 mg | -63.20 | Standard Deviation 18.59 | Percent Change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Dextrometh-rophan 30 mg + Lomitapide 60 mg | -46.07 | Standard Deviation 33.12 | Percent Change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | ER Niacin 1000 mg + Lomitapide 10 mg | -20.89 | Standard Deviation 15.17 | Percent Change |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorvastatin 20 mg + Lomitapide 10 mg | 16 | |
| Overall Study | STARTED | Simvastatin 20 mg + Lomitapide 10 mg | 15 | |
| Overall Study | STARTED | Ezetimibe 10 mg + Lomitapide 10 mg | 10 | |
| Overall Study | STARTED | Rosuvastatin 20 mg + Lomitapide 10 mg | 10 | |
| Overall Study | STARTED | Fenofibrate 145 mg + Lomitapide 10 mg | 10 | |
| Overall Study | STARTED | Atorvastatin 20 mg + Lomitapide 60 mg | 15 | |
| Overall Study | STARTED | Rosuvastatin 20 mg + Lomitapide 60 mg | 18 | |
| Overall Study | STARTED | Dextrometh-rophan 30 mg + Lomitapide 60 mg | 15 | |
| Overall Study | STARTED | ER Niacin 1000 mg + Lomitapide 10 mg | 20 | |
| Overall Study | COMPLETED | Atorvastatin 20 mg + Lomitapide 10 mg | 15 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events333
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 | Atorvastatin 20 mg + Lomitapide 10 mg | 3 | 16 | |
| other | Diarrhoea | Gastrointestinal disorders | Simvastatin 20 mg + Lomitapide 10 mg | 4 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe 10 mg + Lomitapide 10 mg | 1 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Rosuvastatin 20 mg + Lomitapide 10 mg | 0 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Fenofibrate 145 mg + Lomitapide 10 mg | 3 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 20 mg + Lomitapide 60 mg | 7 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Rosuvastatin 20 mg + Lomitapide 60 mg | 9 | 18 | |
| other | Diarrhoea | Gastrointestinal disorders | Dextrometh-rophan 30 mg + Lomitapide 60 mg | 4 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | ER Niacin 1000 mg + Lomitapide 10 mg | 2 | 20 | |
| other | Nausea | Gastrointestinal disorders | Atorvastatin 20 mg + Lomitapide 10 mg | 1 | 16 |
1 to 10 of 333Source ClinicalTrials.gov
See all 333 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorvastatin 20 mg + Lomitapide 10 mg | ||
| Total, all-cause mortality | Simvastatin 20 mg + Lomitapide 10 mg | ||
| Total, all-cause mortality | Ezetimibe 10 mg + Lomitapide 10 mg | ||
| Total, all-cause mortality | Rosuvastatin 20 mg + Lomitapide 10 mg | ||
| Total, all-cause mortality | Fenofibrate 145 mg + Lomitapide 10 mg | ||
| Total, all-cause mortality | Atorvastatin 20 mg + Lomitapide 60 mg | ||
| Total, all-cause mortality | Rosuvastatin 20 mg + Lomitapide 60 mg | ||
| Total, all-cause mortality | Dextrometh-rophan 30 mg + Lomitapide 60 mg | ||
| Total, all-cause mortality | ER Niacin 1000 mg + Lomitapide 10 mg | ||
| Total, other adverse events | Atorvastatin 20 mg + Lomitapide 10 mg | 8 | 16 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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/NCT00359281
GET https://conductscience.org/api/trials/v1/NCT00359281/flow?page=2