Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT01982461
Status:
UNKNOWN
Last Update Posted:
2013-11-13
First Post:
2013-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-11-06', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks.', 'timeFrame': 'baseline to week 12'}], 'secondaryOutcomes': [{'measure': 'The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.', 'timeFrame': 'baseline to week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 20 to 85;\n* LDL - C between 130 mg/dL and 250 mg/dL;\n* TG \\< 400 mg/dL;\n* Who without use of any statin within 2 week prior to the trial;\n* Informed consent given.\n\nExclusion Criteria:\n\n* Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy;\n* Active liver disease/severe hepatic impairment(Child-Pugh C,ALT2×ULN);\n* Treatment with Cyclosporin or any disallowed drug;\n* Patients with unstable angina pectoris;\n* Pregnant, lactating women;\n* Patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the trial.'}, 'identificationModule': {'nctId': 'NCT01982461', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pin Siang Medical Biotechnology Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Roty F.C. Tablets 10mg Versus Crestor 10mg F.C. Tablets in Patients With Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'PSMB102ROS10-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin', 'description': 'One Rosuvastatin tablet 10mg taken once daily.', 'interventionNames': ['Drug: Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crestor®', 'description': 'One Crestor® tablet 10mg taken once daily.', 'interventionNames': ['Drug: Crestor®']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Roty'], 'description': '10mg,once daily', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'Crestor®', 'type': 'DRUG', 'otherNames': ['Rosuvastatin'], 'description': '10mg,once daily', 'armGroupLabels': ['Crestor®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11490', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'role': 'CONTACT', 'email': 'tsghirb@ndmctsgh.edu.tw', 'phone': '886-2-87923311', 'phoneExt': '10552'}], 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Lu-Hsin Lu, M.S.', 'role': 'CONTACT', 'email': 'flora@twtungda.com.tw', 'phone': '886-2-26270255', 'phoneExt': '206'}], 'overallOfficials': [{'name': 'Yi-Jen Hung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tri-Service General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pin Siang Medical Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}