Trial · NCT01350999
Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
NCT01350999, Phase 3, Completed, Takeda; results first posted 2016-09-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia. Trials, record NCT01350999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01350999
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
- NCT number
- NCT01350999
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 503 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypertriglyceridemia
- Interventions
- omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA)
- First posted
- 2011-05-10
- Last updated
- 2016-09-20
- Results first posted
- 2016-09-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 52 Weeks | |
| Primary | Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | 52 Weeks | |
| Primary | Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight | 52 Weeks | |
| Primary | Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration | 52 Weeks | Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure. |
| Primary | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | 52 Weeks | |
| Secondary | Percent Change From Baseline in Triglyceride Level | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | |
| Secondary | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | |
| Secondary | Percent Change From Baseline in Total Cholesterol | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | |
| Secondary | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol. |
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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 52 Weeks | Safety Analysis Set included all participants who received at least one dose of the investigational product. | participants | NUMBER |
| PRIMARY | Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | 52 Weeks | Safety Analysis Set included all participants who received at least one dose of the investigational product. | participants | NUMBER |
| PRIMARY | Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight | 52 Weeks | Safety Analysis Set included all participants who received at least one dose of the investigational product. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration | 52 Weeks | Safety Analysis Set included all participants who received at least one dose of the investigational product. | participants | NUMBER |
| PRIMARY | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | 52 Weeks | Safety Analysis Set included all participants who received at least one dose of the investigational product. | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Triglyceride Level | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Full analysis set (all participants who were randomized and received at least one dose of the investigational product) with available data at each time point (indicated by n). | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Full analysis set with available data at each time point (indicated by n). | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Full analysis set with available data at each time point (indicated by n). | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Full analysis set with available data at each time point (indicated by n). | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Full analysis set with available data at each time point (indicated by n). | percent change | MEAN |
Source ClinicalTrials.gov
Results by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TAK-085 2 g | 106 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TAK-085 4 g | 110 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | EPA-E 1.8 g | 109 | participants | ||
| Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | TAK-085 2 g | 0 | 12.58 | participants | |
| Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | TAK-085 4 g | 0 | 12.64 | participants | |
| Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | EPA-E 1.8 g | 0 | 12.80 | participants | |
| Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight | TAK-085 2 g | 0 | 0.907 | participants | |
| Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight | TAK-085 4 g | 0 | 0.870 | participants | |
| Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight | EPA-E 1.8 g | 0 | 0.919 | participants | |
| Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration | TAK-085 2 g | 0 | participants |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAK-085 2 g | 165 | |
| Overall Study | STARTED | TAK-085 4 g | 171 | |
| Overall Study | STARTED | EPA-E 1.8 g | 167 | |
| Overall Study | Treated | TAK-085 2 g | 165 | |
| Overall Study | Treated | TAK-085 4 g | 171 | |
| Overall Study | Treated | EPA-E 1.8 g | 167 | |
| Overall Study | COMPLETED | TAK-085 2 g | 157 | |
| Overall Study | COMPLETED | TAK-085 4 g | 157 | |
| Overall Study | COMPLETED | EPA-E 1.8 g | 146 | |
| Overall Study | NOT COMPLETED | TAK-085 2 g | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events102
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 | Nasopharyngitis | Infections and infestations | TAK-085 2 g | 57 | 165 | |
| other | Nasopharyngitis | Infections and infestations | TAK-085 4 g | 43 | 171 | |
| other | Nasopharyngitis | Infections and infestations | EPA-E 1.8 g | 42 | 167 | |
| other | Pharyngitis | Infections and infestations | TAK-085 2 g | 14 | 165 | |
| other | Pharyngitis | Infections and infestations | TAK-085 4 g | 15 | 171 | |
| other | Pharyngitis | Infections and infestations | EPA-E 1.8 g | 15 | 167 | |
| other | Bronchitis | Infections and infestations | TAK-085 2 g | 9 | 165 | |
| other | Bronchitis | Infections and infestations | TAK-085 4 g | 7 | 171 | |
| other | Bronchitis | Infections and infestations | EPA-E 1.8 g | 9 | 167 | |
| other | Seasonal allergy | Immune system disorders | TAK-085 2 g | 6 | 165 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAK-085 2 g | ||
| Total, all-cause mortality | TAK-085 4 g | ||
| Total, all-cause mortality | EPA-E 1.8 g | ||
| Total, other adverse events | TAK-085 2 g | 96 | 165 |
| Total, other adverse events | TAK-085 4 g | 94 | 171 |
| Total, other adverse events | EPA-E 1.8 g | 104 | 167 |
| Total, serious adverse events | TAK-085 2 g | 5 | 165 |
| Total, serious adverse events | TAK-085 4 g | 10 | 171 |
| Total, serious adverse events | EPA-E 1.8 g | 7 | 167 |
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/NCT01350999
GET https://conductscience.org/api/trials/v1/NCT01350999/results?page=2