Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT03527069
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-04', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of serum triglyceride levels measured between the first visit and last visit.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events recorded during the study.', 'timeFrame': '13 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertriglyceridemia', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants of both sexes, aged 18 years or more;\n* Participants with the diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;\n* Signed consent.\n\nExclusion Criteria:\n\n* Diagnosis of familial hypercholesterolemia and other genetic diseases;\n* Using medications that may interfere with the metabolism or serum levels of triglycerides;\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* Presence of concomitant cardiovascular disease, renal failure and hepatic Failure;\n* Decompensated diabetes;\n* Current smoking;\n* History hypersensitivity to the active ingredients used in the study;\n* Pregnancy or risk of pregnancy and lactating patients;\n* History of alcohol abuse or illicit drug use;\n* Participation in clinical trial in the year prior to this study.'}, 'identificationModule': {'nctId': 'NCT03527069', 'briefTitle': 'Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment', 'orgStudyIdInfo': {'id': 'EMS0617-CIPROS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIPROS 10', 'description': 'The study is double-Masked, the patient wil take 2 tablets, as follow:\n\n1 tablet Cipros 10 association; and\n\n1 tablet crestor placebo Oral, once a day.', 'interventionNames': ['Drug: Cipros 10 association']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crestor', 'description': 'The study is double-Masked, the patient wil take 2 tablets, as follow:\n\n1 tablet Crestor 10mg; and\n\n1 tablet Cipros association placebo Oral, once a day.', 'interventionNames': ['Drug: Crestor 10 mg']}], 'interventions': [{'name': 'Cipros 10 association', 'type': 'DRUG', 'otherNames': ['EMS association'], 'description': 'oral, once a day.', 'armGroupLabels': ['CIPROS 10']}, {'name': 'Crestor 10 mg', 'type': 'DRUG', 'otherNames': ['Rosuvastatin 10 mg'], 'description': 'oral, once a day.', 'armGroupLabels': ['Crestor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Allergisa', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}