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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 August 2016 |
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Main ID: |
NCT00280995 |
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Date of registration:
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20/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
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Scientific title:
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A Phase 2, Open-Label, Dose Escalation Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00280995 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Netherlands
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genzyme, a Sanofi Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Weight = 40 kg for Cohorts A, B, & C; Weight = 50 kg for Cohort D
- Diagnosis of Homozygous Familial Hypercholesterolemia.
- Female must be non-pregnant and non-lactating.
- On stable lipid lowering therapy for at least 4 weeks.
- Lipid values that 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypercholesterolemia, Familial
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Intervention(s)
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Drug: ISIS 301012
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Primary Outcome(s)
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Percent reduction in LDL-cholesterol from baseline
[Time Frame: Week 7 (Cohorts A-C), Week 15 (Cohort D)]
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Secondary ID(s)
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EudraCT No.: 2005-004796-38
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301012CS8
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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