Trial · NCT01047683
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
NCT01047683, Phase 3, Completed, Amarin Pharma Inc.; results first posted 2022-04-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL. Trials, record NCT01047683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01047683
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
- NCT number
- NCT01047683
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 229 participants, actual
- Lead sponsor
- Amarin Pharma Inc.
- Conditions
- Hypertriglyceridemia
- Interventions
- AMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day, Placebo
- First posted
- 2010-01-13
- Last updated
- 2022-04-25
- Results first posted
- 2022-04-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect | baseline and 12 weeks | Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day |
| Secondary | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels | baseline and 12 weeks | Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day |
| Secondary | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels | baseline and 12 weeks | Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day |
| Secondary | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels | baseline and 12 weeks | Median in percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day |
| Other | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels | baseline and 12 weeks | Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day |
| Other | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels | baseline and 12 weeks | Median percent change from baseline to Week 12 in serum non-high density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect | baseline and 12 weeks | Intent-to-treat population: randomized patients who received \>= 1 dose of study drug and had baseline and \>= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Percent change from baseline | MEDIAN |
| SECONDARY | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels | baseline and 12 weeks | Intent-to-treat population: randomized patients who received \>= 1 dose of study drug and had baseline and \>= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Percent change from baseline | MEDIAN |
| SECONDARY | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels | baseline and 12 weeks | Intent-to-treat population: randomized patients who received \>= 1 dose of study drug and had baseline and \>= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Percent change from baseline | MEDIAN |
| SECONDARY | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels | baseline and 12 weeks | Intent-to-treat population: randomized patients who received \>= 1 dose of study drug and had baseline and \>= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Percent change from baseline | MEDIAN |
| OTHER_PRE_SPECIFIED | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels | baseline and 12 weeks | Intent-to-treat population: randomized patients who received \>= 1 dose of study drug and had baseline and \>= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Percent change from baseline | MEDIAN |
| OTHER_PRE_SPECIFIED | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels | baseline and 12 weeks | Intent-to-treat population: randomized patients who received \>= 1 dose of study drug and had baseline and \>= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Percent change from baseline | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect | AMR101 (Ethyl Icosapentate) - 2 g/Day | -7.0 | Inter-Quartile Range -30.1 to 18.6 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect | AMR101 (Ethyl Icosapentate) - 4 g/Day | -26.6 | Inter-Quartile Range -41.1 to 0.0 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect | Placebo | 9.7 | Inter-Quartile Range -19.2 to 42.3 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels | AMR101 (Ethyl Icosapentate) - 2 g/Day | 0.0 | Inter-Quartile Range -22.5 to 29.2 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels | AMR101 (Ethyl Icosapentate) - 4 g/Day | -19.5 | Inter-Quartile Range -35.7 to 19.6 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels | Placebo | 13.7 | Inter-Quartile Range -13.5 to 55.3 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels | AMR101 (Ethyl Icosapentate) - 2 g/Day | -5.1 | Inter-Quartile Range -17.1 to 7.1 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels | AMR101 (Ethyl Icosapentate) - 4 g/Day | -17.1 | Inter-Quartile Range -26.2 to -1.7 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels | Placebo | -2.4 | Inter-Quartile Range -15.9 to 13.5 | Percent change from baseline | |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels | AMR101 (Ethyl Icosapentate) - 2 g/Day | 2.1 | Inter-Quartile Range -4.7 to 7.6 | Percent change from baseline |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 76 | |
| Overall Study | STARTED | AMR101 (Ethyl Icosapentate) - 2 g/Day | 76 | |
| Overall Study | STARTED | AMR101 (Ethyl Icosapentate) - 4 g/Day | 77 | |
| Overall Study | COMPLETED | Placebo | 71 | |
| Overall Study | COMPLETED | AMR101 (Ethyl Icosapentate) - 2 g/Day | 70 | |
| Overall Study | COMPLETED | AMR101 (Ethyl Icosapentate) - 4 g/Day | 74 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | AMR101 (Ethyl Icosapentate) - 2 g/Day | 6 | |
| Overall Study | NOT COMPLETED | AMR101 (Ethyl Icosapentate) - 4 g/Day | 3 |
Source ClinicalTrials.gov
Adverse events15
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 | Diarrhea | Gastrointestinal disorders | Placebo | 5 | 76 | |
| other | Diarrhea | Gastrointestinal disorders | AMR101 (Ethyl Icosapentate) - 2 g/Day | 4 | 76 | |
| other | Diarrhea | Gastrointestinal disorders | AMR101 (Ethyl Icosapentate) - 4 g/Day | 1 | 77 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 76 | |
| other | Nausea | Gastrointestinal disorders | AMR101 (Ethyl Icosapentate) - 2 g/Day | 5 | 76 | |
| other | Nausea | Gastrointestinal disorders | AMR101 (Ethyl Icosapentate) - 4 g/Day | 1 | 77 | |
| other | Eructation | Gastrointestinal disorders | Placebo | 3 | 76 | |
| other | Eructation | Gastrointestinal disorders | AMR101 (Ethyl Icosapentate) - 2 g/Day | 1 | 76 | |
| other | Eructation | Gastrointestinal disorders | AMR101 (Ethyl Icosapentate) - 4 g/Day | 0 | 77 | |
| serious | Coronary artery disease | Cardiac disorders | Placebo | 0 | 76 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | AMR101 (Ethyl Icosapentate) - 2 g/Day | ||
| Total, all-cause mortality | AMR101 (Ethyl Icosapentate) - 4 g/Day | ||
| Total, other adverse events | Placebo | 12 | 76 |
| Total, other adverse events | AMR101 (Ethyl Icosapentate) - 2 g/Day | 10 | 76 |
| Total, other adverse events | AMR101 (Ethyl Icosapentate) - 4 g/Day | 2 | 77 |
| Total, serious adverse events | Placebo | 0 | 76 |
| Total, serious adverse events | AMR101 (Ethyl Icosapentate) - 2 g/Day | 1 | 76 |
| Total, serious adverse events | AMR101 (Ethyl Icosapentate) - 4 g/Day | 1 | 77 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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.
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