Trial · NCT00690443
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
NCT00690443, Phase 2, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2013-02-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia. Trials, record NCT00690443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00690443
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
- NCT number
- NCT00690443
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Hypercholesterolemia
- Interventions
- Atorvastatin, AEGR-733
- First posted
- 2008-06-04
- Last updated
- 2018-02-23
- Results first posted
- 2013-02-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in LDL-C After 8 Weeks of Therapy | Baseline and 8 weeks of treatment | |
| Secondary | Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Baseline and 4 weeks |
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 Change in LDL-C After 8 Weeks of Therapy | Baseline and 8 weeks of treatment | Percent Change | MEAN | |
| SECONDARY | Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Baseline and 4 weeks | Percent | MEAN |
Source ClinicalTrials.gov
Results by group20
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 After 8 Weeks of Therapy | Atorvastatin 20 mg | -39.6 | Standard Deviation 14.35 | Percent Change | |
| Percent Change in LDL-C After 8 Weeks of Therapy | Atorvastatin 20 mg + Lomitapide | -49.9 | Standard Deviation 26.78 | Percent Change | |
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Atorvastatin 20 mg | Change in LDL-C | -42.5 | Standard Deviation 12.70 | Percent |
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Atorvastatin 20 mg + Lomitapide | Change in LDL-C | -51.0 | Standard Deviation 18.34 | Percent |
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Atorvastatin 20 mg | Change in TC | -31.3 | Standard Deviation 9.23 | Percent |
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Atorvastatin 20 mg + Lomitapide | Change in TC | -38.1 | Standard Deviation 15.38 | Percent |
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Atorvastatin 20 mg | Change in TGs | -21.5 | Standard Deviation 18.31 | Percent |
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Atorvastatin 20 mg + Lomitapide | Change in TGs | -17.8 | Standard Deviation 28.32 | Percent |
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Atorvastatin 20 mg | Change in HDL-C | 6.7 | Standard Deviation 8.07 | Percent |
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Atorvastatin 20 mg + Lomitapide | Change in HDL-C | -1.9 | Standard Deviation 10.73 | Percent |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorvastatin 20 mg | 23 | |
| Overall Study | STARTED | Atorvastatin 20 mg + Lomitapide | 21 | |
| Overall Study | COMPLETED | Atorvastatin 20 mg | 22 | |
| Overall Study | COMPLETED | Atorvastatin 20 mg + Lomitapide | 19 | |
| Overall Study | NOT COMPLETED | Atorvastatin 20 mg | 1 | |
| Overall Study | NOT COMPLETED | Atorvastatin 20 mg + Lomitapide | 2 |
Source ClinicalTrials.gov
Adverse events22
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 | 3 | 23 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 20 mg + Lomitapide | 10 | 21 | 10 |
| other | Flatuence | Gastrointestinal disorders | Atorvastatin 20 mg | 2 | 23 | 2 |
| other | Flatuence | Gastrointestinal disorders | Atorvastatin 20 mg + Lomitapide | 4 | 21 | 4 |
| other | Nausea | Gastrointestinal disorders | Atorvastatin 20 mg | 2 | 23 | 2 |
| other | Nausea | Gastrointestinal disorders | Atorvastatin 20 mg + Lomitapide | 3 | 21 | 3 |
| other | Headache | Nervous system disorders | Atorvastatin 20 mg | 2 | 23 | 2 |
| other | Headache | Nervous system disorders | Atorvastatin 20 mg + Lomitapide | 3 | 21 | 3 |
| other | Alanine aminotransferase increased | Investigations | Atorvastatin 20 mg | 0 | 23 | 0 |
| other | Alanine aminotransferase increased | Investigations | Atorvastatin 20 mg + Lomitapide | 4 | 21 | 4 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorvastatin 20 mg | ||
| Total, all-cause mortality | Atorvastatin 20 mg + Lomitapide | ||
| Total, other adverse events | Atorvastatin 20 mg | 16 | 23 |
| Total, other adverse events | Atorvastatin 20 mg + Lomitapide | 16 | 21 |
| Total, serious adverse events | Atorvastatin 20 mg | 0 | 23 |
| Total, serious adverse events | Atorvastatin 20 mg + Lomitapide | 0 | 21 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atorvastatin 20 mg vs Atorvastatin 20 mg + Lomitapide: serious adverse events |
Source Trial comparisons
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/NCT00690443
GET https://conductscience.org/api/trials/v1/NCT00690443/events?page=2