Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-03-01 @ 10:11 AM
Study NCT ID:
NCT00664859
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2008-04-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bbu@veloxis.com', 'phone': '919-591-3090', 'title': 'Director, Regulatory Affairs', 'organization': 'Veloxis Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "The study is a multicenter collaborative investigation and the clinical trial results are to be published as a collaborative manuscript. Authorship will reflect varying levels of individual contribution to the study by the individual PI's.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LCP-AtorFen 40/100mg', 'description': 'Data presented by previous double-blind study assignment', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 12, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Atorvastatin 40 mg', 'description': 'Data presented by previous double-blind study assignment', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 21, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Fenofibrate 145 mg', 'description': 'Data presented by previous double-blind study assignment', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 21, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCP-AtorFen 40/100mg', 'description': 'Data presented by previous double-blind study assignment'}, {'id': 'OG001', 'title': 'Atorvastatin 40 mg', 'description': 'Data presented by previous double-blind study assignment'}, {'id': 'OG002', 'title': 'Fenofibrate 145 mg', 'description': 'Data presented by previous double-blind study assignment'}], 'classes': [{'title': 'Non-HDL cholesterol, change from DB baseline', 'categories': [{'measurements': [{'value': '-48.2', 'spread': '13.58', 'groupId': 'OG000'}, {'value': '-43.6', 'spread': '18.18', 'groupId': 'OG001'}, {'value': '-42.0', 'spread': '20.49', 'groupId': 'OG002'}]}]}, {'title': 'Non-HDL cholesterol change from OL baseline', 'categories': [{'measurements': [{'value': '2.6', 'spread': '22.39', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '33.67', 'groupId': 'OG001'}, {'value': '-29.6', 'spread': '26.92', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides change from DB baseline', 'categories': [{'measurements': [{'value': '-53.1', 'spread': '25.31', 'groupId': 'OG000'}, {'value': '-51.2', 'spread': '23.23', 'groupId': 'OG001'}, {'value': '-42.1', 'spread': '29.96', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides change from OL baseline', 'categories': [{'measurements': [{'value': '11.4', 'spread': '65.36', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '40.42', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '53.27', 'groupId': 'OG002'}]}]}, {'title': 'HDL cholesterol change from DB baseline', 'categories': [{'measurements': [{'value': '22.1', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '18.67', 'groupId': 'OG001'}, {'value': '17.5', 'spread': '20.21', 'groupId': 'OG002'}]}]}, {'title': 'HDL cholesterol change from OL baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '17.77', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '15.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks from DB baseline and 40 weeks from OL baseline', 'description': 'Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LCP-AtorFen 40/100mg', 'description': 'Data presented by previous double-blind study assignment'}, {'id': 'OG001', 'title': 'Atorvastatin 40 mg', 'description': 'Data presented by previous double-blind study assignment'}, {'id': 'OG002', 'title': 'Fenofibrate 145 mg', 'description': 'Data presented by previous double-blind study assignment'}], 'classes': [{'title': 'LDL-C change from DB baseline', 'categories': [{'measurements': [{'value': '-44.8', 'spread': '15.92', 'groupId': 'OG000'}, {'value': '-39.3', 'spread': '20.04', 'groupId': 'OG001'}, {'value': '-40.9', 'spread': '22.0', 'groupId': 'OG002'}]}]}, {'title': 'LDL-C change from OL baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '25.09', 'groupId': 'OG000'}, {'value': '14', 'spread': '36.29', 'groupId': 'OG001'}, {'value': '-33.6', 'spread': '24.26', 'groupId': 'OG002'}]}]}, {'title': 'VLDL-C change from DB baseline', 'categories': [{'measurements': [{'value': '-53.6', 'spread': '23.98', 'groupId': 'OG000'}, {'value': '-51.1', 'spread': '23.07', 'groupId': 'OG001'}, {'value': '-42.0', 'spread': '29.94', 'groupId': 'OG002'}]}]}, {'title': 'VLDL-C change from OL baseline', 'categories': [{'measurements': [{'value': '12.7', 'spread': '69.42', 'groupId': 'OG000'}, {'value': '-18.7', 'spread': '39.97', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '51.98', 'groupId': 'OG002'}]}]}, {'title': 'Total-C change from DB baseline', 'categories': [{'measurements': [{'value': '-36.5', 'spread': '11.07', 'groupId': 'OG000'}, {'value': '-33.8', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '-32.8', 'spread': '16.08', 'groupId': 'OG002'}]}]}, {'title': 'Total-C change from OL baseline', 'categories': [{'measurements': [{'value': '1.5', 'spread': '12.95', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '24.54', 'groupId': 'OG001'}, {'value': '-24.4', 'spread': '19.04', 'groupId': 'OG002'}]}]}, {'title': 'Apo A-1 change from DB baseline', 'categories': [{'measurements': [{'value': '3.2', 'spread': '13.21', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '9.88', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Apo-A-1 change from OL baseline', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '8.11', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '13.62', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '11.36', 'groupId': 'OG002'}]}]}, {'title': 'Apo B change from DB baseline', 'categories': [{'measurements': [{'value': '-42.4', 'spread': '11.85', 'groupId': 'OG000'}, {'value': '-38.9', 'spread': '16.26', 'groupId': 'OG001'}, {'value': '-36.8', 'spread': '18.81', 'groupId': 'OG002'}]}]}, {'title': 'Apo B change from OL baseline', 'categories': [{'measurements': [{'value': '3.1', 'spread': '17.69', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '25.14', 'groupId': 'OG001'}, {'value': '-25.5', 'spread': '21.59', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks from DB baseline and 40 weeks from OL baseline', 'description': 'Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52)', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LCP-AtorFen 40/100 mg', 'description': 'Subjects randomized to LCP-AtorFen 40/100 mg/day in the DB portion of the study'}, {'id': 'FG001', 'title': 'Atorvastatin 40 mg', 'description': 'Subjects randomized to Atorvastatin 40 mg/day in the DB portion of the study'}, {'id': 'FG002', 'title': 'Fenofibrate 145 mg', 'description': 'Subjects randomized to Fenofibrate 145 mg/day in the DB portion of the study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'DB Study (LCP-AtorFen-2001) AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Noncompliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Laboratory abnormality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Of the 192 subjects who completed the double-blind (DB) period, 140 rolled over into the extension study and received at least one dose of open-label (OL) study drug to form the safety population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LCP-AtorFen 40/100mg', 'description': 'Data presented by previous double-blind study assignment'}, {'id': 'BG001', 'title': 'Atorvastatin 40 mg', 'description': 'Data presented by previous double-blind study assignment'}, {'id': 'BG002', 'title': 'Fenofibrate 145 mg', 'description': 'Data presented by previous double-blind study assignment'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '10.86', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '9.03', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '11.23', 'groupId': 'BG002'}, {'value': '55.7', 'spread': '10.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Amer. Indian /Alaskan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Black/African', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Hawaiian/Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2008-04-21', 'resultsFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-02', 'studyFirstPostDateStruct': {'date': '2008-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment', 'timeFrame': '52 weeks from DB baseline and 40 weeks from OL baseline', 'description': 'Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52)'}], 'secondaryOutcomes': [{'measure': 'Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment', 'timeFrame': '52 weeks from DB baseline and 40 weeks from OL baseline', 'description': 'Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LCP-AtorFen', 'Non-HDL cholesterol', 'Triglycerides', 'HDL cholesterol', 'LDL cholesterol', 'Atorvastatin', 'Fenofibrate'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia', 'detailedDescription': 'POPULATION:\n\nSubjects with mixed dyslipidemia (non-HDL cholesterol \\> 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label extension study.\n\nSTUDY DESIGN AND DURATION:\n\nThis is a 52-week, open-label, single-treatment arm with 8 visits (Weeks 0, 4, 8, 12, 24, 36, 48 and 52). A maximum of approximately 200 subjects will enter this open-label safety and efficacy extension study from the LCP AtorFen-2001 double-blind study. All subjects enrolled in this study will receive open-label LCP-AtorFen combination therapy. Visit 1 of the extension study corresponds to the last visit of the double-blind study (Visit 6 or Week 12).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829).\n2. Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with Good Clinical Practice (GCP).\n\nExclusion Criteria:\n\n1. Study drug compliance \\<70% in the double-blind study.\n2. Any ongoing serious adverse event, or any ongoing non-serious moderate or severe adverse event from the double-blind study that is rated as possibly, probably or definitely related to study drug.\n3. Resting blood pressure \\>/=160 mm Hg systolic and/or \\>/=100 mm Hg diastolic.\n4. Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.\n5. Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study.\n6. Any clinically significant change from Visit 1 to Visit 6 of the double-blind study in medical history including, but not limited to: a diagnosis of insulin-dependent diabetes mellitus (DM); poorly controlled DM; poorly controlled hypertension; significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease; cancer (except non-melanoma skin cancer); and epilepsy.\n7. Unwilling to abstain from medications, supplements, ingredients and herbal therapies that were excluded in the double-blind study and continue to be excluded in the open-label study.\n8. Women who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential (not surgically sterilized between menarche and menopause) who are not using a medically approved method of contraception.\n9. Other exclusion conditions might apply.'}, 'identificationModule': {'nctId': 'NCT00664859', 'briefTitle': '12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Veloxis Pharmaceuticals'}, 'officialTitle': 'A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia', 'orgStudyIdInfo': {'id': 'LCP-AtorFen-2001-1X'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single', 'description': 'Open-label LCP-AtorFen', 'interventionNames': ['Drug: LCP-AtorFen']}], 'interventions': [{'name': 'LCP-AtorFen', 'type': 'DRUG', 'otherNames': ['atorvastatin and fenofibrate combination therapy'], 'description': 'All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals.', 'armGroupLabels': ['Single']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Radiant Research, 515 N State St, Suite 2700', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jeff Geohas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiant Research'}, {'name': 'Dennis McCluskey, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Resaerch'}, {'name': 'Harry Geisberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'Chivers Woodruff, Jr, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'Michael Noss, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'Michele Reynolds, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'James Zavoral, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'Randall Severance, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'Stephen Halpern, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'Linda Murray, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'Eduardo Cuevas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiant Research'}, {'name': 'Cynthia Strout, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Coastal Carolina Research'}, {'name': 'Mark Kipnes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Diabetes and Glandular Research Center, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Veloxis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}