At a glance
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Phase I/II Study of Simvastatin (Zocor) Therapy in Sickle Cell Disease
In Brief
A Phase 2 clinical trial evaluating Simvastatin for Sickle Cell Disease. Completed, enrolled 42 participants across 1 site.
Detailed Summary
Recent clinical and experimental data indicate that statins have effects beyond cholesterol lowering that may be beneficial in sickle cell disease by protecting the vascular endothelium. Statins have been shown to attenuate endothelial dysfunction through their anti-inflammatory, anti-oxidant and anti-thrombotic properties. This phase I/II dose-escalating trial is designed to assess the safety and potential clinical efficacy of oral simvastatin (Zocor)in adolescents and adults with sickle cell disease (SCD).
Study Details
Timeline
Interventions
Comparison of 3 dosages of simvastatin given in a dose-escalating fashion. 20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days.