Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00688558
Status:
COMPLETED
Last Update Posted:
2008-06-03
First Post:
2008-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C411602', 'term': 'dalcetrapib'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-02', 'studyFirstSubmitDate': '2008-05-29', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% change from baseline in HDL-C; inhibition of CETP activity', 'timeFrame': '4-weeks'}], 'secondaryOutcomes': [{'measure': '% change from baseline in LDL-C and TC/HDL-C', 'timeFrame': '4-weeks'}, {'measure': 'Plasma concentration of JTT-705', 'timeFrame': '4-weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with low HDL'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having lipid values as indicated below:\n* HDL-C ≤ 1.0 mmol/L (40 mg/dL)\n* TG ≤4.5 mmol/L (400 mg/dL)\n* Patients with CHD or CHD risk equivalent\n* Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)\n\nExclusion Criteria:\n\n* Body Mass Index of ≥ 35 kg/m2\n* Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception\n* Concomitant use of medications identified in the protocol'}, 'identificationModule': {'nctId': 'NCT00688558', 'briefTitle': 'Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akros Pharma Inc.'}, 'officialTitle': 'A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Simvastatin 40 mg in Patients With Low HDL Levels', 'orgStudyIdInfo': {'id': 'AT705-X-03-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'JTT-705 600 mg and simvastatin 40 mg', 'interventionNames': ['Drug: JTT-705 600 mg and simvastatin 40 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo and simvastatin 40 mg', 'interventionNames': ['Drug: Placebo and simvastatin 40 mg']}], 'interventions': [{'name': 'JTT-705 600 mg and simvastatin 40 mg', 'type': 'DRUG', 'description': '* JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment\n* Simvastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, immediately following breakfast and/or assessments', 'armGroupLabels': ['1']}, {'name': 'Placebo and simvastatin 40 mg', 'type': 'DRUG', 'description': '* Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments\n* Simvastatin 40 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'state': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akros Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Shoji Hoshino, DVM, Vice President, Clinical Development', 'oldOrganization': 'Akros Pharma Inc.'}}}}