Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT01166633
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2010-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'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': 'C108475', 'term': 'pitavastatin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': '1.Changes in ALT after treatment', 'timeFrame': '12 weeks'}, {'measure': '2.Changes in AST after treatment', 'timeFrame': '12 weeks'}, {'measure': '3.Changes in LDL-C, TC, TG and HDL-C after treatment', 'timeFrame': '12 weeks'}, {'measure': '4.Changes in fat in liver after treatment', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydroxymethylglutaryl-CoA Reductase Inhibitors', 'hyperlipidemia'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged between 25 and 75\n* Patients who signed informed consent forms of their own volition;\n* Patients who had taken statins for 2 months and longer or whose fasting LDL-C levels, were 130mg/dL and over (Friedewald's formula);\n* Patients whose ALT levels were 1.25 to 2.5 times higher than the upper limit of normal\n\nExclusion Criteria:\n\n* Patients with uncompensated liver cirrhosis.\n* Patients whose total bilirubin levels were over 2 times higher than the upper limit of normal.\n* Patients who had taken antiviral drugs for viral hepatitis.\n* Patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (NYHA class IV).\n* Patients whose triglyceride(TG) levels were 400mg/dL or higher.\n* Patients with uncontrolled hypertension (DBP≧100mmHg)\n* Patients under suspicion of renal dysfunction (serum creatinine≧2.0mg/dL)\n* Patients whose CK levels were over 2.5 times higher than the upper limit of normal.\n* Patients with uncontrolled hypothyroidism although drug treatment (TSH≧ULN×1.5)\n* Female patients who were nursing or being pregnant or were planning on becoming pregnant.\n* Patients judged to be unsuitable by investigators."}, 'identificationModule': {'nctId': 'NCT01166633', 'acronym': 'PITCH', 'briefTitle': 'Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Pharmaceutical'}, 'officialTitle': 'A Randomized , Open Label, Dose Titration Study to Evaluate the Effect of Pitavastatin Versus Atorvastatin in Patients With Hypercholesterolemia and Mild to Moderate Hepatic Damage', 'orgStudyIdInfo': {'id': 'CWP-PTV-707'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pitavastatin 2 mg', 'interventionNames': ['Drug: pitavastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin 10mg', 'interventionNames': ['Drug: atorvastatin']}], 'interventions': [{'name': 'pitavastatin', 'type': 'DRUG', 'otherNames': ['LIVALO'], 'description': 'pitavastatin 2mg per daily', 'armGroupLabels': ['Pitavastatin 2 mg']}, {'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['LIPITOR'], 'description': 'atorvastatin 10mg per daily', 'armGroupLabels': ['Atorvastatin 10mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kyoo-Rok Han', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangdong Sacred Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}