Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 12:28 PM
Study NCT ID:
NCT00739050
Status:
TERMINATED
Last Update Posted:
2024-05-23
First Post:
2008-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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': 'The Investigator was not able to recruit the required patients and was not able to get the necessary equipment. The protocol was terminated for Administrative Reasons.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Simvastatin', 'description': 'simvastatin 20 mg daily at nights for 12 weeks', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo daily at nights for 12 weeks', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'simvastatin 20 mg daily at nights for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily at nights for 12 weeks'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'The study was terminated; no outcome measure data analyses were conducted.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'simvastatin 20 mg daily at nights for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily at nights for 12 weeks'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'The study was terminated; no outcome measure data analyses were conducted.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'simvastatin 20 mg daily at nights for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily at nights for 12 weeks'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'The study was terminated; no outcome measure data analyses were conducted.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'simvastatin 20 mg daily at nights for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily at nights for 12 weeks'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'The study was terminated; no outcome measure data analyses were conducted.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simvastatin', 'description': 'simvastatin 20 mg daily at nights for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo daily at nights for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'These 3 patients completing treatment did not complete the required procedures during the trial.', 'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient enrolled (FPE): 19 Sept 2007; Last patient enrolled (LPE) 22 Oct 2007. The protocol was terminated for Administrative Reasons'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All Randomized patients.\n\nLaboratory values were only avaliable for 3 participants for Total Cholesterol, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '176.67', 'spread': '28.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'N=3 (Completed Participants)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low Density Lipoprotein Cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '105', 'spread': '23.64', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'N=3 (Completed Participants)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Density Lipoprotein Cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '10.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'N=3 (Completed Participants)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2008-08-19', 'resultsFirstSubmitDate': '2010-08-26', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-11-16', 'studyFirstPostDateStruct': {'date': '2008-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The study was terminated; no outcome measure data analyses were conducted.'}], 'secondaryOutcomes': [{'measure': 'Change in Total Cholesterol From Baseline at Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The study was terminated; no outcome measure data analyses were conducted.'}, {'measure': 'Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The study was terminated; no outcome measure data analyses were conducted.'}, {'measure': 'Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The study was terminated; no outcome measure data analyses were conducted.'}]}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Patients Over 18 Years Old\n* Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)\n* Signed Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Patients With LDL-C Below 90 mg/dL\n* Pregnant Or Breast Feeding\n* Diabetes Mellitus\n* Or Any Clinically Relevant Organ Disfunction'}, 'identificationModule': {'nctId': 'NCT00739050', 'briefTitle': 'Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': '0733-271'}, 'secondaryIdInfos': [{'id': '2008_021'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Arm 1: Drug', 'interventionNames': ['Drug: simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Arm 2: Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor', 'MK0733'], 'description': 'simvastatin 20mg daily at nights for 12 weeks. Tablets', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'placebo daily at nights for 12 weeks. Tablets', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}