Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
Study NCT ID:
NCT03947866
Status:
UNKNOWN
Last Update Posted:
2023-02-16
First Post:
2019-05-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ezetimibe-Rosuvastatin Evaluation Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-10', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C', 'timeFrame': '12 months', 'description': 'Levels of LDL-C'}], 'secondaryOutcomes': [{'measure': 'Lipidemic profile', 'timeFrame': '12 months', 'description': 'HDL-C↑ T-CHOL, Triglycerides measurements'}, {'measure': 'Cardiovascular risk factor', 'timeFrame': '12 months', 'description': 'Response of patients vs target of total cardiovascular risk to which they belong.'}, {'measure': 'Adverse Events', 'timeFrame': '12 months', 'description': 'Number of Adverse Events during the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia', 'Hyperlipidemias', 'Combinations of Drugs; Dependence']}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in achieving the target plasma LCL-C level.', 'detailedDescription': 'Additional study objectives:\n\n1. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia with respect to changes in the rest of the lipid profile (HDL-C, TC, TG).\n2. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-HDL cholesterol (non-HDL - cholesterol) levels.\n3. The assessment of the achievement of the LCL-C target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category.\n4. Assessing patient safety throughout treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hyperlcholesterolaemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who have voluntarily consented to participate in the study.\n* Adult patients who are already on treatment with the stable combination of ezetimibe-rosuvastatin (Lipopen), at the discretion of the treating physician.\n* Adult patient adequately controlled with rosuvastatin and ezetimibe according to ESC / EAS 2019 guidelines.\n\nExclusion Criteria:\n\n* Patients who have not fully understood the study procedures and have not signed the consent form.\n* Patients who are contraindicated for taking the drug according to the Summary of Product Characteristics (MSF) of the study drug.\n\nHypersensitivity to the active substances or to any of the excipients of Lipopen.\n\n* Pregnancy and breastfeeding.\n* Active liver disease involving unexplained, persistent increases in serum transaminases and any increase in serum transaminases that exceeds 3 times the normal upper limit (ULN) or unexplained persistent increases in serum transaminases.\n* Patient with severe renal impairment (creatinine clearance \\<30 ml / min).\n* Patient with myopathy\n* Patient receiving concomitant treatment with cyclosporine'}, 'identificationModule': {'nctId': 'NCT03947866', 'acronym': 'ZEUS', 'briefTitle': 'Ezetimibe-Rosuvastatin Evaluation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elpen Pharmaceutical Co. Inc.'}, 'officialTitle': 'An Observational Clinical Study to Evaluate the Effectiveness of Fixed-dose Combination of eZEtimibe-rosUvaStatin.', 'orgStudyIdInfo': {'id': '2022-ROSEZE-EL-160'}}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'CHARALAMPOS VLAHOPOULOS', 'role': 'CONTACT', 'email': 'cvlachop@med.uoa.gr', 'phone': '0030 213 208.8000'}], 'facility': 'Athens University Hospital HIPPOKRATEION', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elpen Pharmaceutical Co. Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}