Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-27 @ 5:27 AM
Study NCT ID:
NCT00079859
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2004-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'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': 'C443181', 'term': 'implitapide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-10'}, 'statusVerifiedDate': '2005-04', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2004-03-17', 'studyFirstSubmitQcDate': '2004-03-17', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Heterozygous Familial Hypercholesterolemia (HeFH)'], 'conditions': ['Familial Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to participate in this study, patients must meet all of the following inclusion criteria:\n\n* be between 18 and 70 years old with a diagnosis of HeFH;\n* be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;\n* have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;\n* be male or nonpregnant, nonlactating female;\n* give informed consent; and\n* meet body weight requirements.\n\nExclusion Criteria:\n\nIn order to participate in this study, patients must not meet any of the following exclusion criteria:\n\n* recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;\n* uncontrolled hypothyroidism or other uncontrolled endocrine disease;\n* known, clinically significant eye abnormalities (e.g., cataracts);\n* appropriate serum creatinine phosphokinase levels;\n* history of liver disease or liver enzyme levels above appropriate levels;\n* alkaline phosphatase above appropriate levels;\n* serum creatinine above appropriate levels;\n* liver cirrhosis and severe liver steatosis;\n* clinically significant infection, malignancy, or psychosis;\n* use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks;\n* participation in any other investigational study, including device or observational studies, within 30 days;\n* lactating or have a positive serum pregnancy test;\n* current drug or alcohol abuse; or\n* unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator'}, 'identificationModule': {'nctId': 'NCT00079859', 'briefTitle': 'Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medical Research Laboratories International'}, 'officialTitle': 'Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy', 'orgStudyIdInfo': {'id': 'MRL 2002-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implitapide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metabolic and Atherosclerosis Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Andromed Leiden', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Andromed Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Velp', 'country': 'Netherlands', 'facility': 'Andromed Oost', 'geoPoint': {'lat': 51.995, 'lon': 5.97361}}, {'city': 'Zoetermeer', 'country': 'Netherlands', 'facility': 'Andromed Zoetermeer', 'geoPoint': {'lat': 52.0575, 'lon': 4.49306}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Lipidklinikken - Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Research Laboratories International', 'class': 'INDUSTRY'}}}}