Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT00231569
Status:
COMPLETED
Last Update Posted:
2016-08-03
First Post:
2005-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose-escalating Safety Study in Subjects on Stable Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], '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': 'C524142', 'term': 'mipomersen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2005-10-03', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent reduction in LDL-cholesterol from baseline', 'timeFrame': 'From baseline measurement'}], 'secondaryOutcomes': [{'measure': 'Percent reduction in apoB-100', 'timeFrame': 'From baseline measurement'}, {'measure': 'Percent change in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL plus LDL-cholesterol and LDL-cholesterol particle size and concentration', 'timeFrame': 'From baseline measurement'}, {'measure': 'Percent change from baseline in LDL/HDL and apoB-100/apo-A1 ratios', 'timeFrame': 'From baseline measurement'}, {'measure': 'AEs, SAEs, physical examination data, vital signs, and laboratory analyzes', 'timeFrame': 'Duration of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LDL-cholesterol', 'apoB-100', 'apoB-48'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '20378080', 'type': 'DERIVED', 'citation': 'Akdim F, Stroes ES, Sijbrands EJ, Tribble DL, Trip MD, Jukema JW, Flaim JD, Su J, Yu R, Baker BF, Wedel MK, Kastelein JJ. Efficacy and safety of mipomersen, an antisense inhibitor of apolipoprotein B, in hypercholesterolemic subjects receiving stable statin therapy. J Am Coll Cardiol. 2010 Apr 13;55(15):1611-8. doi: 10.1016/j.jacc.2009.11.069.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on Stable statin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On a stable dose of \\>/= 40 mg Simvastatin or atorvastatin daily for \\>/= 3 months prior to baseline and expected to remain on this dose for the remainder of the study\n* LDL-cholesterol between 2.60 and 5.70 mmol/L (100 and 220 mg/dL), inclusive at screening\n* Females not of childbearing potential.\n\nExclusion Criteria:\n\n* History of CHD or CHD-equivalent (such as diabetes mellitus, or another clinical form of atherosclerotic disease, e.g., peripheral arterial disease, abdominal aortic aneurysm, or symptomatic carotid artery disease)\n* Fasting triglyceride \\>2.26 mmol/L (200 mg/dL) at screening\n* Any uncontrolled medical/surgical/psychiatric condition, including conditions that may predispose to secondary hypercholesterolemia\n* Current diagnosis or known history of complement deficiency or abnormality\n* A positive hepatitis B surface antigen or hepatitis C antibody, or a known positive HIV status\n* Current diagnosis or known history of liver disease, or has an ALT \\>ULN at screening\n* Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or has a CPK \\>ULN at screening\n* Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin that has been adequately treated\n* The advisability of a subject taking any prescription medication (apart from simvastatin or atorvastatin) within 6 weeks prior to screening should be discussed with the Isis Medical Monitor\n* Subject unwilling to discontinue taking alternative/herbal medication for the duration of the study\n* History of drug abuse within 2 years of screening\n* Subject unwilling to limit alcohol consumption for the duration of the study: male subjects to a maximum of 3 drinks (30 g) per day, and \\<12 drinks (120 g) per week; female subjects to a maximum of 2 drinks (20 g) per day, and \\<8 drinks (80 g) per week\n* Known allergy or hypersensitivity to simvastatin\n* Undergoing or has undergone treatment with another investigational drug, biologic agent, or device within 3 months, or 3 half lives, prior to screening, whichever is longer'}, 'identificationModule': {'nctId': 'NCT00231569', 'briefTitle': 'Dose-escalating Safety Study in Subjects on Stable Statin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kastle Therapeutics, LLC'}, 'officialTitle': 'A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety and Pharmacodynamics of ISIS 301012 in Hypercholesterolemic Subjects on Stable Statin Therapy', 'orgStudyIdInfo': {'id': '301012CS4'}, 'secondaryIdInfos': [{'id': 'EudraCT No.: 2005-002119-26'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A', 'description': 'Loading doses followed by weekly maintenance doses', 'interventionNames': ['Drug: ISIS 301012 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B', 'description': 'Loading doses followed by weekly maintenance doses', 'interventionNames': ['Drug: ISIS 301012 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C', 'description': 'Loading doses followed by weekly maintenance doses', 'interventionNames': ['Drug: ISIS 301012 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D', 'description': 'Loading doses followed by weekly maintenance doses', 'interventionNames': ['Drug: ISIS 301012 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort E', 'description': 'Loading doses followed by weekly maintenance doses', 'interventionNames': ['Drug: ISIS 301012 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort F', 'description': 'Loading doses followed by extended weekly maintenance doses', 'interventionNames': ['Drug: ISIS 301012 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort G', 'description': 'Loading doses followed by extended weekly maintenance doses', 'interventionNames': ['Drug: ISIS 301012 or Placebo']}], 'interventions': [{'name': 'ISIS 301012 or Placebo', 'type': 'DRUG', 'description': '30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29', 'armGroupLabels': ['Cohort A']}, {'name': 'ISIS 301012 or Placebo', 'type': 'DRUG', 'description': '100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29', 'armGroupLabels': ['Cohort B']}, {'name': 'ISIS 301012 or Placebo', 'type': 'DRUG', 'description': '200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29', 'armGroupLabels': ['Cohort C']}, {'name': 'ISIS 301012 or Placebo', 'type': 'DRUG', 'description': '300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29', 'armGroupLabels': ['Cohort D']}, {'name': 'ISIS 301012 or Placebo', 'type': 'DRUG', 'description': '400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29', 'armGroupLabels': ['Cohort E']}, {'name': 'ISIS 301012 or Placebo', 'type': 'DRUG', 'description': '200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85', 'armGroupLabels': ['Cohort F']}, {'name': 'ISIS 301012 or Placebo', 'type': 'DRUG', 'description': '300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85', 'armGroupLabels': ['Cohort G']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2311 GZ', 'city': 'Leiden', 'country': 'Netherlands', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3021 HC', 'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kastle Therapeutics, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Genzyme Coporation'}}}}