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Effect of Niacin/Laropiprant on Lipoprotein(a) Concentration
NCT01321034Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2011
- Primary completion
- Aug 2012
- Countries
- 1
- Sponsor
- Instituto Aragonés de Ciencias de la Salud
- Modality
- Small Molecules
- Drugs
- niacin
- Conditions
- hypercholesterolemia
01
Overview
Phase 4, open-label, single-arm trial of niacin in hypercholesterolemia, sponsored by Instituto Aragonés de Ciencias de la Salud. Primary endpoint: Absolute and relative Lipoprotein(a) lowering effect at 8 weeks. Started Oct 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Niacin/Laropiprant
Subjects with normal, high, and very high Lp(a) receiving Niacin/Laropiprant
03
Who it enrols
Adults aged 18-79 with LDL cholesterol between 70 and 190 mg/dL, triglycerides < 500 mg/dL, and stable Lp(a) levels. Excludes patients with significant liver disease, elevated creatinine, active peptic ulcer, recent clinical gout, uncontrolled diabetes, or recent changes in lipid-lowering therapy.
04
Endpoints
Primary
Absolute and relative Lipoprotein(a) lowering effect
Secondary
Absolute and relative Lipoprotein(a) lowering effect depending on kringle IV-2 repeated copies
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