Trial · NCT02173158
Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
NCT02173158, Phase 3, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2018-10-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy. Trials, record NCT02173158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02173158
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
- NCT number
- NCT02173158
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Familial Hypercholesterolemia - Homozygous
- Interventions
- lomitapide
- First posted
- 2014-06-24
- Last updated
- 2018-10-10
- Results first posted
- 2018-10-10
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 | Baseline to Week 26 | Mean percent change from baseline |
| Secondary | Change in Total Cholesterol | Baseline to Week 56 | Mean percent change from baseline |
| Secondary | Change in Apo B | Baseline to Week 56 | Mean percent change from baseline |
| Secondary | Change in Triglycerides | Baseline to Week 56 | Mean percent change from baseline |
| Secondary | Change in Non-HDL-C | Baseline to Week 56 | Mean percent change from baseline |
| Secondary | Change in VLDL-C | Baseline to Week 56 | Mean percent change from baseline |
| Secondary | Change in Lp(a) | Baseline to Week 56 | Mean percent change from baseline |
| Secondary | Change in HDL-C | Baseline to Week 56 | Mean percent change from baseline |
| Secondary | Change in Apo AI | Baseline to Week 56 | Mean percent change from baseline |
| Secondary | Change in LDL-C | Baseline to Week 56 | Mean percent change from baseline |
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 | Baseline to Week 26 | Full analysis set for the efficacy phase, included all subjects who received study drug and had a baseline and at least one post-baseline assessment | Percent change | MEAN |
| SECONDARY | Change in Total Cholesterol | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
| SECONDARY | Change in Apo B | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
| SECONDARY | Change in Triglycerides | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
| SECONDARY | Change in Non-HDL-C | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
| SECONDARY | Change in VLDL-C | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
| SECONDARY | Change in Lp(a) | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
| SECONDARY | Change in HDL-C | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
| SECONDARY | Change in Apo AI | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
| SECONDARY | Change in LDL-C | Baseline to Week 56 | Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group10
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 | Lomitapide | -42.2 | Standard Deviation 18.16 | Percent change | |
| Change in Total Cholesterol | Lomitapide | -25.9 | Standard Deviation 18.57 | Percent change | |
| Change in Apo B | Lomitapide | -41.4 | Standard Deviation 21.90 | Percent change | |
| Change in Triglycerides | Lomitapide | -44.4 | Standard Deviation 12.70 | Percent change | |
| Change in Non-HDL-C | Lomitapide | -34.6 | Standard Deviation 22.50 | Percent change | |
| Change in VLDL-C | Lomitapide | -44.8 | Standard Deviation 12.05 | Percent change | |
| Change in Lp(a) | Lomitapide | -27.2 | Standard Deviation 23.50 | Percent change | |
| Change in HDL-C | Lomitapide | 5.9 | Standard Deviation 19.64 | Percent change | |
| Change in Apo AI | Lomitapide | -2.8 | Standard Deviation 11.61 | Percent change | |
| Change in LDL-C | Lomitapide | -37.5 | Standard Deviation 24.21 | Percent change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Efficacy Phase | STARTED | Lomitapide | 9 | |
| Efficacy Phase | COMPLETED | Lomitapide | 8 | |
| Efficacy Phase | NOT COMPLETED | Lomitapide | 1 | |
| Safety Phase | STARTED | Lomitapide | 8 | |
| Safety Phase | COMPLETED | Lomitapide | 8 | |
| Safety Phase | NOT COMPLETED | Lomitapide | 0 |
Source ClinicalTrials.gov
Adverse events76
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 | Efficacy Phase | 7 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Safety Phase | 4 | 8 | |
| other | Nausea | Gastrointestinal disorders | Efficacy Phase | 2 | 9 | |
| other | Nausea | Gastrointestinal disorders | Safety Phase | 1 | 8 | |
| other | Abdominal distension | Gastrointestinal disorders | Efficacy Phase | 1 | 9 | |
| other | Abdominal distension | Gastrointestinal disorders | Safety Phase | 0 | 8 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Efficacy Phase | 1 | 9 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Safety Phase | 0 | 8 | |
| other | Dental caries | Gastrointestinal disorders | Efficacy Phase | 1 | 9 | |
| other | Dental caries | Gastrointestinal disorders | Safety Phase | 0 | 8 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efficacy Phase | 0 | 9 |
| Total, all-cause mortality | Safety Phase | 0 | 8 |
| Total, other adverse events | Efficacy Phase | 9 | 9 |
| Total, other adverse events | Safety Phase | 7 | 8 |
| Total, serious adverse events | Efficacy Phase | 0 | 9 |
| Total, serious adverse events | Safety Phase | 1 | 8 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Efficacy Phase vs Safety Phase: deaths from any cause | Trial comparisons |
| Efficacy Phase vs Safety Phase: serious adverse events | 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/NCT02173158
GET https://conductscience.org/api/trials/v1/NCT02173158/events?page=2