Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-01 @ 8:53 AM
Study NCT ID:
NCT00758303
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2013-08-22', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-29', 'studyFirstSubmitDate': '2008-09-23', 'dispFirstSubmitQcDate': '2013-08-29', 'studyFirstSubmitQcDate': '2008-09-23', 'dispFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study', 'timeFrame': 'Baseline to end of 12 weeks of active treatment'}], 'secondaryOutcomes': [{'measure': 'The secondary efficacy parameters include the percent change in total cholesterol (TC), its major lipoprotein sub-fractions and the effects on inflammatory markers', 'timeFrame': 'From baseline to the end of 12 weeks of active treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Triglycerides', 'Cholesterol'], 'conditions': ['Hyperlipidemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cortria.com', 'label': 'Cortria Corporation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness and safety of TRIA-662 (also known as 1-MNA) in treating elevated triglyceride levels in patients not receiving lipid lowering treatment. This study will determine the effects of TRIA-662 on commonly measured blood fats that are known to be important in the prevention of vascular disease.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, dose-ranging, multi-center study. Following a 6-8 week placebo and dietary-controlled baseline period, approximately 195 men and women with either hypertriglyceridemia or mixed hyperlipidemia with serum triglycerides (TG) \\> 200 mg/dl (2.26 mmol/l) will be randomized to receive either placebo, 30 mg TRIA-662 or 90 mg TRIA-662 three times daily for twelve weeks. Lipid and ancillary exploratory parameters will be evaluated at screening, during the baseline period, upon randomisation and throughout the 12-week active treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at least 18 years of age at the time of informed consent (women of childbearing potential must be practicing adequate contraception)\n* Patients with mean serum TG \\> 200 mg/dl (2.26 mmol/l) and \\< 700 mg/dl (7.91 mmol/l) as measured at 2 sequential visits during the dietary controlled baseline period (Visits 2 and 3 or Visits 3 and 3a) and having lower level within 25% of upper level (higher value minus lower value)/higher value \\< 0.25)\n* Patients willing and able to sign an informed consent form and follow the protocol\n\nExclusion Criteria:\n\n* Patients who are pregnant or nursing\n* Patients with evidence of hepatic dysfunction \\[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal (ULN), bilirubin greater than 1.5 times ULN, or cirrhosis\\] or renal dysfunction (serum creatinine greater than 140 μmol/l, or nephrotic syndrome) as measured during the baseline phase\n* Patients with uncontrolled diabetes mellitus (fasting glucose level above 11 mmol/l or HbA1C above 10%) as measured during the baseline phase\n* Patients with hypothyroidism that is not treated or not stable for at least 6 months prior to study entry\n* Patients with uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 110 mm Hg)\n* Patients with systolic blood pressure above 140 mm Hg AND three or more of the following cardiovascular risk factors:\n* Current cigarette smoker\n* HDL-C \\< 40 mg/dL (1.04 mmol/L)\n* Coronary heart disease in male first degree relative \\< 55 years of age\n* Coronary heart disease in female first degree relative \\< 65 years of age\n* Male age 45 years or older\n* Female age 55 years or older\n* Patients with known hyperuricemia or with a history of gout\n* Patients with an active peptic ulcer\n* Patients with known coronary artery disease, cerebrovascular disease or peripheral arterial disease that has previously required percutaneous coronary intervention or surgical intervention\n* Patients with known intolerance or allergy to niacin\n* Patients consuming more than 10 alcoholic drinks per week\n* Patients with a history of drug abuse\n* Patients receiving any lipid modifying agent within 4 weeks of entry into the baseline period\n* Patients participating in another clinical trial within 30 days of entry into the baseline period\n* Patients considered to be non-compliant to study medication (\\< 80% study medication) or diet during the placebo-baseline phase\n* Patients for whom the investigator determines that the study would not be appropriate'}, 'identificationModule': {'nctId': 'NCT00758303', 'briefTitle': 'A Study to Evaluate the Lipid Regulating Effects of TRIA-662', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cortria Corporation'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662', 'orgStudyIdInfo': {'id': 'Cortria-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Low Dose TRIA-662', 'interventionNames': ['Drug: Low Dose TRIA-662']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'High Dose TRIA-662', 'interventionNames': ['Drug: High Dose TRIA-662']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Matching Placebo for TRIA-662', 'interventionNames': ['Drug: Placebo for TRIA-662']}], 'interventions': [{'name': 'Low Dose TRIA-662', 'type': 'DRUG', 'otherNames': ['1-MNA'], 'description': 'One Capsule 3 times a day', 'armGroupLabels': ['1']}, {'name': 'High Dose TRIA-662', 'type': 'DRUG', 'otherNames': ['1-MNA'], 'description': '3 Capsules 3 times daily', 'armGroupLabels': ['2']}, {'name': 'Placebo for TRIA-662', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Matching Placebo for TRIA-662 taken 3 times a day', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean C Tardif, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montreal Heart Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cortria Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}