Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 3:40 AM
Study NCT ID:
NCT00080132
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2004-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], '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': 'C443181', 'term': 'implitapide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-10'}, 'statusVerifiedDate': '2005-04', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2004-03-23', 'studyFirstSubmitQcDate': '2004-03-24', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HTG', 'Hypertriglyceridemia, Fredrickson Type I', 'Hypertriglyceridemia, Fredrickson Type V'], 'conditions': ['Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '8 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 8 and 70 years old with diagnosis of Fredrickson Type I or V HTG\n* be stable on current maximum tolerated triglyceride lowering therapy\n* have a fasting TG level of at least 880 mg/dL (10 mmol/L)\n* be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control\n* must be able to give informed consent or if under the age of 18, parents or legal guardians must give their informed consent\n* meet body weight requirements\n\nExclusion Criteria:\n\n* Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke.\n* Patients with class 3 or 4 heart failure\n* Uncontrolled hypothyroidism or other uncontrolled endocrine disease\n* Known, clinically significant eye abnormalities, such as cataracts\n* History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1\n* Alkaline phosphatase greater than 2 times ULN\n* Serum creatinine greater than 2.0 mg/dL\n* Liver cirrhosis and severe liver steatosis\n* Clinically significant infection, malignancy, or psychosis\n* Use of oral anticoagulants or digoxin unless the dose is stable and is regularly monitored\n* Participation in any other investigational study within the last 30 days\n* Breastfeeding or pregnant\n* Current drug or alcohol abuse\n* Serious or unstable medical conditions that would compromise the patient's safety or successful participation in the study\n* Unwillingness to comply with study procedures or unwillingness to cooperate fully"}, 'identificationModule': {'nctId': 'NCT00080132', 'briefTitle': 'Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medical Research Laboratories International'}, 'officialTitle': 'An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy', 'orgStudyIdInfo': {'id': 'MRL 2002-003'}}, '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}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9711 SG', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Andromed Noord', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2311 GZ', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Andromed Leiden', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3021 HC', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Andromed Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '6883 HM', 'city': 'Velp', 'country': 'Netherlands', 'facility': 'Andromed Oost', 'geoPoint': {'lat': 51.995, 'lon': 5.97361}}, {'zip': '2724 EK', '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'}}}}