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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00281008
Other study ID # 301012CS9
Secondary ID 2005-004797-24
Status Completed
Phase Phase 2
First received January 20, 2006
Last updated August 1, 2016
Start date February 2006
Est. completion date December 2007

Study information

Verified date August 2016
Source Kastle Therapeutics, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
ISIS 301012 or Placebo
50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
ISIS 301012 or Placebo
100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
ISIS 301012 or Placebo
200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Kastle Therapeutics, LLC Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent reduction in LDL-cholesterol from baseline Week 7 (Cohorts A-C), Week 15 (Cohort D) No
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