Trial · NCT00435045
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
NCT00435045, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia. Trials, record NCT00435045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00435045
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
- NCT number
- NCT00435045
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 245 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertriglyceridemia
- Interventions
- Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin, atorvastatin
- First posted
- 2007-02-14
- Last updated
- 2017-02-02
- Results first posted
- 2009-05-12
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins. |
| Secondary | Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Total Cholesterol is the sum of the High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), Very Low Density Lipoproteins (VLDL), and Intermediate Density Lipoproteins (IDL). |
| Secondary | Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | HDL - A complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease. High density lipoprotein cholesterol is the Total Cholesterol minus the sum of the LDL, VLDL and IDL. |
| Secondary | Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | LDL - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease. |
| Secondary | Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Triglycerides - A naturally occurring ester of three fatty acids and glycerol that is the chief constituent of fats and oils. |
| Secondary | Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | VLDL - very-low-density lipoprotein: a plasma lipoprotein with a high lipid content, associated with atherosclerosis. |
| Secondary | Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Apolipoprotein A1 - major protein component of high density lipoprotein (HDL) in plasma. The protein promotes cholesterol efflux from tissues to the liver for excretion. |
| Secondary | Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Apolipoprotein C-III (APOC3) is a very low density lipoprotein (VLDL) protein. APOC3 inhibits lipoprotein lipase and hepatic lipase; it is thought to delay catabolism of triglyceride-rich particles. |
| Secondary | Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Total cholesterol/High density lipoprotein cholesterol |
| Secondary | Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat (MITT) Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | percent change | MEDIAN |
| SECONDARY | Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | percent change | MEDIAN |
| SECONDARY | Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | percent change | MEDIAN |
| SECONDARY | Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | percent change | MEDIAN |
| SECONDARY | Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | percent change | MEDIAN |
| SECONDARY | Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | percent change | MEDIAN |
| SECONDARY | Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | percent change | MEDIAN |
| POST_HOC | Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | percent change | MEDIAN |
| SECONDARY | Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | percent change | MEDIAN |
| SECONDARY | Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Baseline and Week 8 | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | percent change | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Lovaza(Omacor) + Atorvastatin | -40.2 | Inter-Quartile Range -45.3 to -32.5 | percent change | |
| Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Placebo + Atorvastatin | -33.7 | Inter-Quartile Range -39.6 to -28.3 | percent change | |
| Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Lovaza(Omacor) + Atorvastatin | -31.5 | Inter-Quartile Range -36.0 to -25.3 | percent change | |
| Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Placebo + Atorvastatin | -27.4 | Inter-Quartile Range -31.7 to -22.2 | percent change | |
| Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Lovaza(Omacor) + Atorvastatin | 12.4 | Inter-Quartile Range 3.6 to 22.9 | percent change | |
| Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Placebo + Atorvastatin | 10.0 | Inter-Quartile Range -1.2 to 16.3 | percent change | |
| Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Lovaza(Omacor) + Atorvastatin | -29.3 | Inter-Quartile Range -41.1 to -18.4 | percent change | |
| Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Placebo + Atorvastatin | -31.5 | Inter-Quartile Range -41.4 to -23.4 | percent change | |
| Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Lovaza(Omacor) + Atorvastatin | -45.4 | Inter-Quartile Range -55.3 to -34.9 | percent change | |
| Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Placebo + Atorvastatin | -26.9 | Inter-Quartile Range -38.7 to -14.4 | percent change |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Weeks 1-8 / 10 mg Dose Level | STARTED | Lovaza(Omacor) + Atorvastatin | 123 | |
| Weeks 1-8 / 10 mg Dose Level | STARTED | Placebo + Atorvastatin | 122 | |
| Weeks 1-8 / 10 mg Dose Level | COMPLETED | Lovaza(Omacor) + Atorvastatin | 118 | |
| Weeks 1-8 / 10 mg Dose Level | COMPLETED | Placebo + Atorvastatin | 118 | |
| Weeks 1-8 / 10 mg Dose Level | NOT COMPLETED | Lovaza(Omacor) + Atorvastatin | 5 | |
| Weeks 1-8 / 10 mg Dose Level | NOT COMPLETED | Placebo + Atorvastatin | 4 | |
| Weeks 9-12 / 20mg Dose Level | STARTED | Lovaza(Omacor) + Atorvastatin | 118 | |
| Weeks 9-12 / 20mg Dose Level | STARTED | Placebo + Atorvastatin | 118 | |
| Weeks 9-12 / 20mg Dose Level | COMPLETED | Lovaza(Omacor) + Atorvastatin | 113 | |
| Weeks 9-12 / 20mg Dose Level | COMPLETED | Placebo + Atorvastatin | 113 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events12
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 |
|---|---|---|---|---|---|---|
| serious | Cholecystitis Acute | Hepatobiliary disorders | Lovaza(Omacor) + Atorvastatin | 0 | 122 | |
| serious | Cholecystitis Acute | Hepatobiliary disorders | Placebo + Atorvastatin | 1 | 122 | |
| serious | Syncope | Nervous system disorders | Lovaza(Omacor) + Atorvastatin | 0 | 122 | |
| serious | Syncope | Nervous system disorders | Placebo + Atorvastatin | 1 | 122 | |
| serious | Peripheral Ischemia | Vascular disorders | Lovaza(Omacor) + Atorvastatin | 1 | 122 | |
| serious | Peripheral Ischemia | Vascular disorders | Placebo + Atorvastatin | 0 | 122 | |
| serious | Lobar Pneumonia | Infections and infestations | Lovaza(Omacor) + Atorvastatin | 1 | 122 | |
| serious | Lobar Pneumonia | Infections and infestations | Placebo + Atorvastatin | 0 | 122 | |
| serious | Chest Pain/ Dyspnea | Respiratory, thoracic and mediastinal disorders | Lovaza(Omacor) + Atorvastatin | 1 | 122 | |
| serious | Chest Pain/ Dyspnea | Respiratory, thoracic and mediastinal disorders | Placebo + Atorvastatin | 0 | 122 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lovaza(Omacor) + Atorvastatin | ||
| Total, all-cause mortality | Placebo + Atorvastatin | ||
| Total, other adverse events | Lovaza(Omacor) + Atorvastatin | 0 | 123 |
| Total, other adverse events | Placebo + Atorvastatin | 0 | 122 |
| Total, serious adverse events | Lovaza(Omacor) + Atorvastatin | 4 | |
| Total, serious adverse events | Placebo + Atorvastatin | 2 |
Source ClinicalTrials.gov
Papers2
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.
GET https://conductscience.org/api/trials/v1/NCT00435045
GET https://conductscience.org/api/trials/v1/NCT00435045/registered?page=2