Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT00891293
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2009-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'C405603', 'term': 'Omacor'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'LOV111821/OM5XX was terminated due to the lack of substantial incremental change in the primary endpoint lipid values above that reached in either the original study (LOV111859/OM5) or the first extension study (LOV111860/OM5X).'}}, 'adverseEventsModule': {'description': 'While 93 subjects were enrolled in the study, information for serious adverse events and other adverse events is provided for 89 subjects. These 89 subjects represent the Safety Population. The Safety Population is defined as all subjects who received a dose of study medication and had at least one post-enrollment safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day', 'otherNumAffected': 47, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Elevated liver function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'L2-3 herniated lumbar disk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'R lower extremity cellulitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Serum Triglycerides From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '-60.6', 'spread': '20.72', 'groupId': 'OG000', 'lowerLimit': '-85.3', 'upperLimit': '55.9'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '-62.0', 'spread': '32.33', 'groupId': 'OG000', 'lowerLimit': '-88.9', 'upperLimit': '115.0'}]}]}], 'analyses': [{'pValue': '0.9999', 'groupIds': ['OG000'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '9.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.01', 'estimateComment': 'Difference Between Percent Change from LOV111859/OM5 Baseline to LOV111860/OM5X End-of-Treatment and Percent Change from LOV111859/OM5 Baseline to LOV111821/OM5XX End-of-Treatment', 'groupDescription': 'For the MITT analysis, the method of last observation carried forward (LOCF) was applied. The LOCF is the value of a previous non-baseline visit (post-enrollment) carried forward to the subsequent visit, if missing.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat (MITT) Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Cholesterol From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-47.6', 'upperLimit': '25.3'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '-13.2', 'groupId': 'OG000', 'lowerLimit': '-55.1', 'upperLimit': '20.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in Total Cholesterol (Total-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Total-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in VLDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '-58.3', 'groupId': 'OG000', 'lowerLimit': '-82.2', 'upperLimit': '14.9'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '-54.6', 'groupId': 'OG000', 'lowerLimit': '-88.4', 'upperLimit': '10.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in very low density lipoprotein-cholesterol (VLDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of VLDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in LDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000', 'lowerLimit': '-24.8', 'upperLimit': '147.7'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '-49.0', 'upperLimit': '159.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in low density lipoprotein-cholesterol (LDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of LDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-62.9', 'upperLimit': '44.1'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '-11.1', 'groupId': 'OG000', 'lowerLimit': '-47.2', 'upperLimit': '175.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Ratio of Total-C:HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Ext. Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '-4.8', 'groupId': 'OG000', 'lowerLimit': '-45.2', 'upperLimit': '234.6'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-72.4', 'upperLimit': '74.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in the ratio of total cholesterol (Total-C) to high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change for the ratio of Total-C to HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Apo A-1 From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-68.6', 'upperLimit': '34.4'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '-20.4', 'upperLimit': '179.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in apolipoprotein (apo) A-1 from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo A-1 from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Apo B From LOV111859/OM5 (Double-blind [DB[ Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-39.9', 'upperLimit': '47.6'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '-7.3', 'groupId': 'OG000', 'lowerLimit': '-59.3', 'upperLimit': '35.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in apolipoprotein (apo) B from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo B from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Non-HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'classes': [{'title': 'LOV111859/OM5 Baseline to LOV111860/OM5X EOT', 'categories': [{'measurements': [{'value': '-7.2', 'groupId': 'OG000', 'lowerLimit': '-51.4', 'upperLimit': '30.9'}]}]}, {'title': 'LOV111859/OM5 Baseline to LOV111821/OM5XX EOT', 'categories': [{'measurements': [{'value': '-13.3', 'groupId': 'OG000', 'lowerLimit': '-64.8', 'upperLimit': '20.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change of non- high density lipoprotein-cholesterol (non-HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of non-HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '93 participants were enrolled; baseline data are provided for 89 participants (Safety Population).', 'groupId': 'FG000', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Laboratory abnormality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Sponsor termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lovaza (Formerly Known as Omacor) and Fenofibrate', 'description': 'Open-label Lovaza (omega-3-acid ethyl esters)\\[formerly known as Omacor\\] 4 g/day and open-label fenofibrate 130 mg/day'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '9.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-22', 'studyFirstSubmitDate': '2009-04-30', 'resultsFirstSubmitDate': '2009-05-06', 'studyFirstSubmitQcDate': '2009-04-30', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-04', 'studyFirstPostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Serum Triglycerides From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension).', 'timeFrame': 'Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Total Cholesterol From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study).', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in Total Cholesterol (Total-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Total-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}, {'measure': 'Percent Change in VLDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in very low density lipoprotein-cholesterol (VLDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of VLDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}, {'measure': 'Percent Change in LDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in low density lipoprotein-cholesterol (LDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of LDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}, {'measure': 'Percent Change in HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}, {'measure': 'Percent Change in Ratio of Total-C:HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Ext. Study)', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in the ratio of total cholesterol (Total-C) to high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change for the ratio of Total-C to HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}, {'measure': 'Percent Change in Apo A-1 From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in apolipoprotein (apo) A-1 from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo A-1 from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}, {'measure': 'Percent Change in Apo B From LOV111859/OM5 (Double-blind [DB[ Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change in apolipoprotein (apo) B from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo B from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}, {'measure': 'Percent Change in Non-HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)', 'timeFrame': 'LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24', 'description': 'Median Percent Change of non- high density lipoprotein-cholesterol (non-HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of non-HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['omega-3-acid ethyl esters', 'Very high triglycerides', 'Lovaza', 'fenofibrate'], 'conditions': ['Hypertriglyceridemia']}, 'referencesModule': {'references': [{'pmid': '19597368', 'type': 'BACKGROUND', 'citation': 'Roth EM, Bays HE, Forker AD, Maki KC, Carter R, Doyle RT, Stein EA. Prescription omega-3 fatty acid as an adjunct to fenofibrate therapy in hypertriglyceridemic subjects. J Cardiovasc Pharmacol. 2009 Sep;54(3):196-203. doi: 10.1097/FJC.0b013e3181b0cf71.'}]}, 'descriptionModule': {'briefSummary': 'This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza (omega-3-acid ethyl esters) \\[formerly known as Omacor\\] therapy in hypertriglyceridemic subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.', 'detailedDescription': 'Three studies comprise this program. Study LOV111859/OM5 (double-blind study) was followed by two open label extensions - LOV111860/OM5X (1st open label extension - 8 weeks) and LOV111821/OM5XX (2nd open label extension - 24 months).\n\nStudies LOV111859/OM5 and LOV111860/OM5X are outlined in NCT00246636.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation.\n\nEligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind LOV111859/OM5 protocol.\n\nSubjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation. The main eligibility criteria for LOV111859/OM5 were,\n\n* 18 to79 years of age (inclusive) at screening\n* fasting serum TG levels ≥500 mg/dL and \\<1300 mg/dL\n* BMI ≥ 25 kg/m2 and ≤43 kg/m2.\n\nSubjects enrolled directly from the end of LOV111860/OM5X into LOV111821/OM5XX.'}, 'identificationModule': {'nctId': 'NCT00891293', 'briefTitle': 'A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™', 'orgStudyIdInfo': {'id': '111821'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)', 'description': 'Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \\[formerly known as Omacor\\]', 'interventionNames': ['Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)']}], 'interventions': [{'name': 'Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)', 'type': 'DRUG', 'description': 'Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) \\[formerly known as Omacor\\]', 'armGroupLabels': ['Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33023', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32259', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational 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Investigational Site', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '62285', 'city': 'Wentzville', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site'}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '28677', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '27106', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '02864', 'city': 'Cumberland', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.96677, 'lon': -71.43284}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'E.D. Derilus; Clinical Disclosure Advisor', 'oldOrganization': 'GSK Clinical Disclosure'}}}}