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| ID | Type | Description | Link |
|---|---|---|---|
| LOV111858 | Other Identifier | GSK |
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In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this posting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin + Lovaza® ("Non-switchers") | Experimental | Open label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + Lovaza® in the double-blind trial, hence in this open-label extension, they are termed "Non-switchers" |
|
| Simvastatin + Lovaza® ("Switchers") | Experimental | Open label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + placebo in the double-blind trial, hence in this open-label extension, they are termed "Switchers" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin + Lovaza® (omega-3-acid ethyl esters) | Drug | Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor] |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Month 4 (LOV111818) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial | Months 4, 12, and 24 (LOV111818) of the open-label extension trial |
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For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8.
FYI - entry criteria for LOV111818/OM6 (double-blind study)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20156032 | Background | Bays HE, Maki KC, McKenney J, Snipes R, Meadowcroft A, Schroyer R, Doyle RT, Stein E. Long-term up to 24-month efficacy and safety of concomitant prescription omega-3-acid ethyl esters and simvastatin in hypertriglyceridemic patients. Curr Med Res Opin. 2010 Apr;26(4):907-15. doi: 10.1185/03007991003645318. | |
| Background | Maki KC, Davidson MH, Doyle RT, Ballantyne C. Effect of Prescription Omega-3 Fatty Acids on Non-HDL Cholesterol (Stratified by Baseline LDL Cholesterol Level) in Statin-Treated Patients With Hypertriglyceridemia: COMBOS LDL Tertile Analysis Short Clinical Communication . [Am J Cardiol]. 2010;105(10):1409-12. | ||
| 20451686 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111818 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-switcher | Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409). |
| FG001 | Switcher |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits 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 |
| Encinitas |
| California |
| 92024 |
| United States |
| GSK Investigational Site | Fresno | California | 93710 | United States |
| GSK Investigational Site | Greenbrae | California | 94904 | United States |
| GSK Investigational Site | Sacramento | California | 95831 | United States |
| GSK Investigational Site | Thousand Oaks | California | 91360 | United States |
| GSK Investigational Site | Hollywood | Florida | 33023 | United States |
| GSK Investigational Site | Pinellas Park | Florida | 33781 | United States |
| GSK Investigational Site | Tampa | Florida | 33606 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30309 | United States |
| GSK Investigational Site | Dunwoody | Georgia | 30328 | United States |
| GSK Investigational Site | Suwanee | Georgia | 30024 | United States |
| GSK Investigational Site | Chicago | Illinois | 60610 | United States |
| GSK Investigational Site | Bloomington | Indiana | 47403 | United States |
| GSK Investigational Site | Evansville | Indiana | 47714 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40213 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21209 | United States |
| GSK Investigational Site | Edina | Minnesota | 55435 | United States |
| GSK Investigational Site | Wentzville | Minnesota | 62285 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64111 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Hickory | North Carolina | 28601 | United States |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | United States |
| GSK Investigational Site | Statesville | North Carolina | 28677 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28412 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27106 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45212 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45246 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | United States |
| GSK Investigational Site | Bristol | Tennessee | 37620 | United States |
| GSK Investigational Site | Plano | Texas | 75093 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23502 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Richmond | Virginia | 23294 | United States |
| GSK Investigational Site | Lakewood | Washington | 98499 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| Background |
| Maki KC, Dicklin MR, Davidson MH, Doyle RT, Ballantyne CM; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy. Am J Cardiol. 2010 May 15;105(10):1409-12. doi: 10.1016/j.amjcard.2009.12.063. Epub 2010 Mar 30. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111818 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111818 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111818 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111818 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111818 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409). |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-switcher | Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409). |
| BG001 | Switcher | Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Number of participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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) | Intent-to-Treat (ITT) Population: Comprised of data for all participants who were enrolled and received at least one dose of study medication | Posted | Median | Full Range | Percent change | Month 4 (LOV111818) |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial | ITT Population | Posted | Median | Full Range | Percent change | Months 4, 12, and 24 (LOV111818) 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 | Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial | ITT Population | Posted | Median | Full Range | Percentage change | LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-switcher | Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409). | 17 | 67 | ||||
| EG001 | Switcher | Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409). | 11 | 79 | ||||
| EG002 | Total Non-switcher and Switcher | Non-switcher and Switcher groups combined | 28 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericardial infusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
|
Only Adverse Experience categories with a greater than 5% occurrence in any group were reported in the AE table.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| C405603 | Omacor |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
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| Male |
|
| Asian |
|
| Black or African American |
|
| Hispanic or Latino |
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|