Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-30 @ 2:27 AM
Study NCT ID:
NCT01239992
Status:
TERMINATED
Last Update Posted:
2014-04-10
First Post:
2010-11-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009525', 'term': 'Niacin'}, {'id': 'C518174', 'term': 'MK-0524'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'klaus.parhofer@med.uni-muenchen.de', 'phone': '+49-89-7095-3010', 'title': 'Klaus G. Parhofer', 'organization': 'University Munich'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Niacin/ Laropiprant', 'description': 'Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Niacin/ Laropiprant', 'description': 'Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-28', 'spread': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'Percent change of incremental AUC at 12 weeks compared to baseline.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Niacin/ Laropiprant', 'description': 'Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'Percent change of HDL-cholesterol at 12 weeks compared to baseline.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fasting Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Niacin/ Laropiprant', 'description': 'Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-26', 'spread': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'Percent change of fasting triglycerides at 12 weeks compared to baseline', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'LDL-cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Niacin/ Laropiprant', 'description': 'Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-20', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'Percent change of LDL-cholesterol at 12 weeks compared to baseline', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Niacin/ Laropiprant', 'description': 'Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Niacin/ Laropiprant', 'description': 'Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '12', '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': 12}}, 'statusModule': {'whyStopped': 'negative endpoint study resulting in withdrawal of study drug', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-12', 'studyFirstSubmitDate': '2010-11-12', 'resultsFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-12', 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'LDL-cholesterol', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'Percent change of LDL-cholesterol at 12 weeks compared to baseline'}], 'primaryOutcomes': [{'measure': 'Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'Percent change of incremental AUC at 12 weeks compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'HDL Cholesterol', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'Percent change of HDL-cholesterol at 12 weeks compared to baseline.'}, {'measure': 'Fasting Triglycerides', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'Percent change of fasting triglycerides at 12 weeks compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipoproteinemia', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers of endothelial dysfunction and inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects or postmenopausal female subjects aged between 19-70 years\n* High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least simvastatin 20 mg/d\n* HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl\n* Lipoprotein (a) \\< 30 mg/dl\n* Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus.\n* Without niacin therapy for at least 6 months\n* Dosage of any concomitant medication has been stable for at least 3 weeks\n* If female, postmenopausal (absence of menstruation for at least 12 months or absence of menstruation \\> 6 months with FSH \\> 40 ng/ml respectively oestrogen \\< 20 pg/ml)\n\nExclusion Criteria:\n\n* Subjects with additional causes for hyperlipoproteinemia\n* Diabetes mellitus or antidiabetic medication\n* Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina\n* History of psychiatric disorder or cognitive impairment that would interfere with participation in the study\n* History of alcoholism\n* Contraindication against niacin and/or laropiprant\n* Subject has participated in an investigational study within 30 days prior to study initiation\n* Fasting triglycerides \\>400 mg/dl\n* Life-threatening disease (e.g. cancer)\n* Renal insufficiency (GFR ≤ 30 ml/min )\n* Major hepatic impairment\n* Known allergic reaction/intolerance against niacin and/or laropiprant\n* Active peptic ulcer disease'}, 'identificationModule': {'nctId': 'NCT01239992', 'briefTitle': 'Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia', 'orgStudyIdInfo': {'id': 'KP-Niacin-2010'}, 'secondaryIdInfos': [{'id': '2010-019954-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Niacin/ Laropiprant', 'interventionNames': ['Drug: Niacin/ Laropiprant']}], 'interventions': [{'name': 'Niacin/ Laropiprant', 'type': 'DRUG', 'otherNames': ['Tredaptive', 'EU/1/08/459/001'], 'description': '1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily', 'armGroupLabels': ['Niacin/ Laropiprant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Klaus Parhofer, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Klaus Parhofer', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}