Trial · NCT00405067
The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia
NCT00405067, 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. The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia. Trials, record NCT00405067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00405067
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia
- NCT number
- NCT00405067
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Hypercholesterolemia
- Interventions
- BMS-201038 (AEGR-733), Ezetimibe
- First posted
- 2006-11-29
- Last updated
- 2014-03-04
- Results first posted
- 2014-03-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments | Baseline and 12 weeks of treatment | |
| Secondary | Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC) | Baseline and 12 weeks of treatment | |
| Secondary | Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline. | Baseline and 12 weeks of treatment | |
| Secondary | Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline | Baseline and 12 weeks of treatment | |
| Secondary | Percent Change in HDL-C at 12 Weeks Compared to Baseline | Baseline and 12 weeks of treatment | |
| Secondary | Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline | Baseline and 12 weeks of treatment | |
| Secondary | Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline | baseline and 12 weeks of treatment | |
| Secondary | Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline | Baseline and 12 weeks of treatment | |
| Secondary | Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline | Baseline and 12 weeks of treatment | |
| Secondary | Percent Change in Body Weight at 12 Weeks as Compared to Baseline | Baseline and 12 weeks of treatment |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments | Baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC) | Baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline. | Baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline | Baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Change in HDL-C at 12 Weeks Compared to Baseline | Baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline | Baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline | baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline | Baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline | Baseline and 12 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Change in Body Weight at 12 Weeks as Compared to Baseline | Baseline and 12 weeks of treatment | Percent Change | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments | Combination Therapy | -46.2 | Standard Deviation 23.8 | Percent Change | |
| Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments | Lomitapide Monotherapy | -29.9 | Standard Deviation 15.3 | Percent Change | |
| Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments | Ezetimibe Monotherapy | -19.6 | Standard Deviation 9.9 | Percent Change | |
| Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC) | Combination Therapy | -34.4 | Standard Deviation 18.8 | Percent Change | |
| Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC) | Lomitapide Monotherapy | -22.8 | Standard Deviation 12.3 | Percent Change | |
| Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC) | Ezetimibe Monotherapy | -12.0 | Standard Deviation 8.7 | Percent Change | |
| Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline. | Combination Therapy | -41.3 | Standard Deviation 22.7 | Percent Change | |
| Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline. | Lomitapide Monotherapy | -26.9 | Standard Deviation 14.6 | Percent Change | |
| Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline. | Ezetimibe Monotherapy | -17.0 | Standard Deviation 10.5 | Percent Change | |
| Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline | Combination Therapy | -7.0 | Standard Deviation 36.0 | Percent Change |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination Therapy | 28 | |
| Overall Study | STARTED | Lomitapide Monotherapy | 28 | |
| Overall Study | STARTED | Ezetimibe Monotherapy | 29 | |
| Overall Study | COMPLETED | Combination Therapy | 24 | |
| Overall Study | COMPLETED | Lomitapide Monotherapy | 19 | |
| Overall Study | COMPLETED | Ezetimibe Monotherapy | 24 | |
| Overall Study | NOT COMPLETED | Combination Therapy | 4 | |
| Overall Study | NOT COMPLETED | Lomitapide Monotherapy | 9 | |
| Overall Study | NOT COMPLETED | Ezetimibe Monotherapy | 5 |
Source ClinicalTrials.gov
Adverse events54
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 | Combination Therapy | 9 | 28 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Lomitapide Monotherapy | 11 | 28 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe Monotherapy | 2 | 29 | 2 |
| other | Alanine aminotransferase increased | Investigations | Combination Therapy | 5 | 28 | 5 |
| other | Alanine aminotransferase increased | Investigations | Lomitapide Monotherapy | 8 | 28 | 8 |
| other | Alanine aminotransferase increased | Investigations | Ezetimibe Monotherapy | 0 | 29 | 0 |
| other | Aspartate aminotransferase increased | Investigations | Combination Therapy | 3 | 28 | 3 |
| other | Aspartate aminotransferase increased | Investigations | Lomitapide Monotherapy | 7 | 28 | 7 |
| other | Aspartate aminotransferase increased | Investigations | Ezetimibe Monotherapy | 0 | 29 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Combination Therapy | 1 | 28 | 1 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Therapy | ||
| Total, all-cause mortality | Lomitapide Monotherapy | ||
| Total, all-cause mortality | Ezetimibe Monotherapy | ||
| Total, other adverse events | Combination Therapy | 24 | 28 |
| Total, other adverse events | Lomitapide Monotherapy | 24 | 28 |
| Total, other adverse events | Ezetimibe Monotherapy | 15 | 29 |
| Total, serious adverse events | Combination Therapy | 0 | 28 |
| Total, serious adverse events | Lomitapide Monotherapy | 1 | 28 |
| Total, serious adverse events | Ezetimibe Monotherapy | 0 | 29 |
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/NCT00405067
GET https://conductscience.org/api/trials/v1/NCT00405067/results?page=2