Trial · NCT00903409
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
NCT00903409, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-08-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects. Trials, record NCT00903409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00903409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
- NCT number
- NCT00903409
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 188 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertriglyceridemia
- Interventions
- Simvastatin + Lovaza® (omega-3-acid ethyl esters)
- First posted
- 2009-05-18
- Last updated
- 2017-10-09
- Results first posted
- 2009-08-04
- Limitations and caveats
- Only Adverse Experience categories with a greater than 5% occurrence in any group were reported in the AE table.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | Month 4 (LOV111818) | Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial) |
| Secondary | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in "Switchers" vs. Non-switchers | Months 4, 12, and 24 (LOV111818) of the open-label extension trial | Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial |
| Secondary | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial | Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | Month 4 (LOV111818) | Intent-to-Treat (ITT) Population: Comprised of data for all participants who were enrolled and received at least one dose of study medication | Percent change | MEDIAN |
| SECONDARY | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Months 4, 12, and 24 (LOV111818) of the open-label extension trial | ITT Population | Percent change | MEDIAN |
| SECONDARY | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial | ITT Population | Percentage change | MEDIAN |
Source ClinicalTrials.gov
Results by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | Non-switcher | 0.9 | Full Range -47.5 to 60 | Percent change | |
| Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | Switcher | -9.4 | Full Range -35.7 to 33.9 | Percent change | |
| Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | Total Non-switcher and Switcher | -3.3 | Full Range -47.5 to 60.0 | Percent change | |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-switcher | Non-HDL-C, Month 4 | -5.4 | Full Range -52.1 to 43.8 | Percent change |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Switcher | Non-HDL-C, Month 4 | -10.3 | Full Range -38.7 to 53.8 | Percent change |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total Non-switcher and Switcher | Non-HDL-C, Month 4 | -8.3 | Full Range -52.1 to 53.8 | Percent change |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-switcher | Non-HDL-C, Month 12 | -6.6 | Full Range -51.9 to 115.6 | Percent change |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Switcher | Non-HDL-C, Month 12 | -8.1 | Full Range -58.6 to 39.4 | Percent change |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total Non-switcher and Switcher | Non-HDL-C, Month 12 | -7.3 | Full Range -58.6 to 115.6 | Percent change |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-switcher | Non-HDL-C, Month 24 | -7.8 | Full Range -47.0 to 97.4 | Percent change |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-switcher | 88 | |
| Overall Study | STARTED | Switcher | 100 | |
| Overall Study | COMPLETED | Non-switcher | 62 | |
| Overall Study | COMPLETED | Switcher | 73 | |
| Overall Study | NOT COMPLETED | Non-switcher | 26 | |
| Overall Study | NOT COMPLETED | Switcher | 27 |
Source ClinicalTrials.gov
Adverse events135
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 | Hypertension | Vascular disorders | Non-switcher | 7 | 85 | |
| other | Hypertension | Vascular disorders | Switcher | 13 | 97 | |
| other | Hypertension | Vascular disorders | Total Non-switcher and Switcher | 20 | 182 | |
| other | Bronchitis | Infections and infestations | Non-switcher | 5 | 85 | |
| other | Bronchitis | Infections and infestations | Switcher | 10 | 97 | |
| other | Bronchitis | Infections and infestations | Total Non-switcher and Switcher | 15 | 182 | |
| other | Sinusitis | Infections and infestations | Non-switcher | 9 | 85 | |
| other | Sinusitis | Infections and infestations | Switcher | 5 | 97 | |
| other | Sinusitis | Infections and infestations | Total Non-switcher and Switcher | 14 | 182 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Non-switcher | 6 | 85 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-switcher | ||
| Total, all-cause mortality | Switcher | ||
| Total, all-cause mortality | Total Non-switcher and Switcher | ||
| Total, other adverse events | Non-switcher | 67 | |
| Total, other adverse events | Switcher | 79 | |
| Total, other adverse events | Total Non-switcher and Switcher | 146 | |
| Total, serious adverse events | Non-switcher | 17 | |
| Total, serious adverse events | Switcher | 11 | |
| Total, serious adverse events | Total Non-switcher and Switcher | 28 |
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/NCT00903409
GET https://conductscience.org/api/trials/v1/NCT00903409/results?page=2