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Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels

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ClinicalTrials.gov Identifier: NCT00216463
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
Ionis Pharmaceuticals, Inc.
Information provided by:
Kastle Therapeutics, LLC

Brief Summary:
The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: ISIS 301012 or Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Varying Loading and Maintenance Dosing Regimens of ISIS 301012 Administered to Hypercholesterolemic Subjects
Study Start Date : August 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
Slow load with every other week maintenance
Drug: 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

Experimental: B
Slow load with every other week maintenance
Drug: 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

Experimental: C
No load; once weekly maintenance
Drug: ISIS 301012 or Placebo
200 mg subcutaneous injection - every week for 13 weeks

Experimental: D
No load; once weekly maintenance
Drug: ISIS 301012 or Placebo
300 mg subcutaneous injection - every week for 13 weeks

Experimental: E
No load; once weekly maintenance
Drug: ISIS 301012 or Placebo
400 mg subcutaneous injection - every week for 13 weeks




Primary Outcome Measures :
  1. Percent reduction in LDL-cholesterol from baseline [ Time Frame: 14 days post dosing ]

Secondary Outcome Measures :
  1. Percent reduction in apoB-100 from baseline [ Time Frame: 14 days post dosing ]
  2. Percent change from baseline in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL and LP(a) [ Time Frame: 14 days post dosing ]
  3. Percent change from baseline in LDL/HDL and apoB-100/apo-A1 ratios [ Time Frame: 14 days post dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >/= 25 to </= 32 kg/m^2
  • 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:

  • No endocrine, hematologic, renal, hepatic, metabolic, psychiatric, neurology, pulmonary or cardiovascular disease
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216463


Locations
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Germany
Berlin, Germany, D-14050
Sponsors and Collaborators
Kastle Therapeutics, LLC
Ionis Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical Monitor, Genzyme Coporation
ClinicalTrials.gov Identifier: NCT00216463     History of Changes
Other Study ID Numbers: 301012CS3
EudraCT No.: 2004-003934-32
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Keywords provided by Kastle Therapeutics, LLC:
LDL-cholesterol
apoB-100
apoB-48
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Mipomersen
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents