Dose-escalating Safety Study in Subjects on Stable Statin Therapy
NCT ID: NCT00231569
Last Updated: 2016-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2005-09-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort A
Loading doses followed by weekly maintenance doses
ISIS 301012 or Placebo
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
Cohort B
Loading doses followed by weekly maintenance doses
ISIS 301012 or Placebo
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
Cohort C
Loading doses followed by weekly maintenance doses
ISIS 301012 or Placebo
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
Cohort D
Loading doses followed by weekly maintenance doses
ISIS 301012 or Placebo
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
Cohort E
Loading doses followed by weekly maintenance doses
ISIS 301012 or Placebo
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
Cohort F
Loading doses followed by extended weekly maintenance doses
ISIS 301012 or Placebo
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
Cohort G
Loading doses followed by extended weekly maintenance doses
ISIS 301012 or Placebo
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
Interventions
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ISIS 301012 or Placebo
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
ISIS 301012 or Placebo
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
ISIS 301012 or Placebo
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
ISIS 301012 or Placebo
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
ISIS 301012 or Placebo
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
ISIS 301012 or Placebo
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
ISIS 301012 or Placebo
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
Eligibility Criteria
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Inclusion Criteria
* LDL-cholesterol between 2.60 and 5.70 mmol/L (100 and 220 mg/dL), inclusive at screening
* Females not of childbearing potential.
Exclusion Criteria
* Fasting triglyceride \>2.26 mmol/L (200 mg/dL) at screening
* Any uncontrolled medical/surgical/psychiatric condition, including conditions that may predispose to secondary hypercholesterolemia
* Current diagnosis or known history of complement deficiency or abnormality
* A positive hepatitis B surface antigen or hepatitis C antibody, or a known positive HIV status
* Current diagnosis or known history of liver disease, or has an ALT \>ULN at screening
* Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or has a CPK \>ULN at screening
* Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin that has been adequately treated
* 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
* Subject unwilling to discontinue taking alternative/herbal medication for the duration of the study
* History of drug abuse within 2 years of screening
* 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
* Known allergy or hypersensitivity to simvastatin
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Kastle Therapeutics, LLC
INDUSTRY
Responsible Party
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Genzyme Coporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Auburn, Maine, United States
Amsterdam, , Netherlands
Leiden, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Countries
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References
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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.
Other Identifiers
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EudraCT No.: 2005-002119-26
Identifier Type: -
Identifier Source: secondary_id
301012CS4
Identifier Type: -
Identifier Source: org_study_id
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