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Mipomersen in severe hypercholesterolemia
NCT00794664Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2009
- Primary completion
- May 2010
- Countries
- 6
- Sponsor
- Kastle Therapeutics LLC
- Modality
- Small Interfering RNA (siRNA), Modified DNA Oligonucleotides, Single-strand DNA
- Drugs
- mipomersen
- Conditions
- hypercholesterolemia
01
Overview
Phase 3, randomised, double-blind trial in hypercholesterolemia comparing Mipomersen with Placebo (2 arms). Primary endpoints: Percent Change From Baseline in Low-density Lipoprotein Cholesterol at 28 weeks and Low-density Lipoprotein Cholesterol at Baseline and Primary Efficacy Time Point at 28 weeks. Started Jan 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Mipomersen
200 mg weekly subcutaneous injections
Placebo
Weekly subcutaneous injections
03
Who it enrols
Patients with severe hypercholesterolemia (LDL-C >= 200 mg/dL with CVD history or >= 300 mg/dL) on stable, maximally tolerated statin therapy and an additional lipid-lowering agent, not on apheresis.
04
Endpoints
Primary
Percent Change From Baseline in Low-density Lipoprotein Cholesterol
Low-density Lipoprotein Cholesterol at Baseline and Primary Efficacy Time Point
Secondary
Percent Change From Baseline in Apolipoprotein B
Percentage Change From Baseline in Total Cholesterol
Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol
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