Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels
NCT ID: NCT00216463
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
50 participants
INTERVENTIONAL
2005-08-31
2007-08-31
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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A
Slow load with every other week maintenance
ISIS 301012 or Placebo
200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 200 mg subcutaneous injection - every other week for 11 weeks
B
Slow load with every other week maintenance
ISIS 301012 or Placebo
200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 100 mg subcutaneous injection - every other week for 11 weeks
C
No load; once weekly maintenance
ISIS 301012 or Placebo
200 mg subcutaneous injection - every week for 13 weeks
D
No load; once weekly maintenance
ISIS 301012 or Placebo
300 mg subcutaneous injection - every week for 13 weeks
E
No load; once weekly maintenance
ISIS 301012 or Placebo
400 mg subcutaneous injection - every week for 13 weeks
Interventions
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ISIS 301012 or Placebo
200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 200 mg subcutaneous injection - every other week for 11 weeks
ISIS 301012 or Placebo
200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 100 mg subcutaneous injection - every other week for 11 weeks
ISIS 301012 or Placebo
300 mg subcutaneous injection - every week for 13 weeks
ISIS 301012 or Placebo
400 mg subcutaneous injection - every week for 13 weeks
ISIS 301012 or Placebo
200 mg subcutaneous injection - every week for 13 weeks
Eligibility Criteria
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Inclusion Criteria
* fasting stable LDL-cholesterol \>/= 130 mg/dL (3.36 mmol/L) and triglycerides \< 400 mg/dL (4.55 mmol/L)
* Females not of childbearing potential
Exclusion Criteria
* Subjects who test positive for hepatitis B, C or HIV
* Current diagnosis or known history of liver disease, such as acute or chronic hepatitis, liver cirrhosis, liver steatosis, or liver function abnormalities such as AST, ALT, GGT, or total bilirubin \>/= 1.5 x ULN at Screening
* A systolic blood pressure \>/= 160 mmHg or a diastolic blood pressure \>/= 95 mmHg on 2 occasions during Screening
* Concomitant medications within 14 days of dosing, except hormone replacement therapy for post-menopausal women and acetylsalicylic acid or paracetamol dosed for fewer than five consecutive days
* Subject has taken any lipid-lowering drug within 30 days or five half-lives (of the lipid-lowering drug) whichever is longer, prior to Screening
* Alcohol or drug abuse within 2 years of Screening
* Donated blood (450 mL) within the 3 months prior to Screening or suffered significant blood loss equal to a blood donor portion
* Subject smokes \> 10 cigarettes, or more than one pipe or one cigar per day
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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Berlin, , Germany
Countries
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References
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Akdim F, Tribble DL, Flaim JD, Yu R, Su J, Geary RS, Baker BF, Fuhr R, Wedel MK, Kastelein JJ. Efficacy of apolipoprotein B synthesis inhibition in subjects with mild-to-moderate hyperlipidaemia. Eur Heart J. 2011 Nov;32(21):2650-9. doi: 10.1093/eurheartj/ehr148. Epub 2011 May 18.
Other Identifiers
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EudraCT No.: 2004-003934-32
Identifier Type: -
Identifier Source: secondary_id
301012CS3
Identifier Type: -
Identifier Source: org_study_id
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