Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy

This study has been completed.
Sponsor:
Collaborator:
Isis Pharmaceuticals
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00281008
First received: January 20, 2006
Last updated: December 2, 2013
Last verified: December 2013

January 20, 2006
December 2, 2013
February 2006
July 2007   (final data collection date for primary outcome measure)
Percent reduction in LDL-cholesterol from baseline [ Time Frame: Week 7 (Cohorts A-C), Week 15 (Cohort D) ] [ Designated as safety issue: No ]
Percent reduction in LDL-cholesterol from baseline
Complete list of historical versions of study NCT00281008 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
A Phase 2, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of ISIS 301012 as Add-on Therapy in Heterozygous Familial Hypercholesterolemia Subjects

The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia, Familial
  • Drug: ISIS 301012 or Placebo
    50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
  • Drug: ISIS 301012 or Placebo
    100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
  • Drug: ISIS 301012 or Placebo
    200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
  • Drug: ISIS 301012 or Placebo
    300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
  • Experimental: Cohort A
    Loading doses followed by weekly maintenance doses
    Intervention: Drug: ISIS 301012 or Placebo
  • Experimental: Cohort B
    Loading doses followed by weekly maintenance doses
    Intervention: Drug: ISIS 301012 or Placebo
  • Experimental: Cohort C
    Loading doses followed by weekly maintenance doses
    Intervention: Drug: ISIS 301012 or Placebo
  • Experimental: Cohort D
    Loading doses followed by extended weekly maintenance doses
    Intervention: Drug: ISIS 301012 or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Weight ≥ 50 kg
  • Diagnosis of Heterozygous Familial Hypercholesterolemia.
  • Females must be non-pregnant and non-lactating.
  • On stable lipid lowering therapy for at least 4 weeks.
  • Lipid levels meet the pre-specified criteria.

Exclusion Criteria:

  • Subject had heart problems in the prior 6 months.
  • Subject has elevated ALT, AST, or CPK.
  • History of renal disease, liver disease, or malignancy.
  • Use of oral anticoagulants, unless the dose has been stable for 4 weeks
  • Have any other conditions, which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
NCT00281008
301012CS9, 2005-004797-24
Not Provided
Medical Monitor, Genzyme Coporation
Genzyme, a Sanofi Company
Isis Pharmaceuticals
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP