Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-06 @ 5:12 AM
Study NCT ID:
NCT00345657
Status:
COMPLETED
Last Update Posted:
2006-06-28
First Post:
2006-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008148', 'term': 'Lovastatin'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2006-06-27', 'studyFirstSubmitDate': '2006-06-27', 'studyFirstSubmitQcDate': '2006-06-27', 'lastUpdatePostDateStruct': {'date': '2006-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid parameter change at 3 and 6 months'}, {'measure': 'Percent of patients achieving ATP III LDL goals at 3 and 6 months'}]}, 'conditionsModule': {'keywords': ['Hyperlipidemia', 'Dyslipidemia', 'Niacin', 'Hydroxymethylglutaryl-CoA Reductase Inhibitors', 'Combination lipid therapy', 'Lovastatin'], 'conditions': ['Hyperlipidemia', 'Mixed Hyperlipidemia', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.', 'detailedDescription': 'Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\>18 years old with CAD or risk factors for CAD\n2. under standard care at Family Medical Care of Tulsa\n3. not at LDL goal per ATP III guidelines\n\nExclusion Criteria:\n\n1. pregnancy/lactating\n2. liver disease\n3. allergies to statin or niacin\n4. active peptic ulcer disease\n5. previous treatment with combination therapy for dyslipidemia'}, 'identificationModule': {'nctId': 'NCT00345657', 'briefTitle': 'Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care', 'organization': {'class': 'OTHER', 'fullName': 'In His Image'}, 'officialTitle': 'Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)', 'orgStudyIdInfo': {'id': 'IHI-A001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Niacin Extended Release/Lovastatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Family Medical Care of Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Jason A Logan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'In His Image Family Medicine Residency'}, {'name': 'Edward Rylander, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'In His Image Family Medicine Residency'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'In His Image', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kos Pharmaceuticals', 'class': 'INDUSTRY'}]}}}