drugset / Trial / NCT01580501

PDE Inhibitors in DMD Study (Acute Dosing Study)

NCT01580501

Phase 1 Completed 12 enrolled Cedars-Sinai Medical Center
NaSingle-groupOpen-labelTreatment

Summary

PDE5A inhibition, which boosts NO-cGMP signaling, will relieve functional muscle ischemia and restore normal blood flow regulation (i.e., functional sympatholysis) during exercise in boys with DMD. The investigators specific aim is to perform an efficient dose-titration study to inform the design of a randomized multicenter trial of PDE5A inhibition for clinical skeletal muscle and cardiac endpoints.

Timeline

Start
2012-03
Primary completion
2013-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Sildenafil Unknown 0.5 mg/kg
Subject Sildenafil Unknown 1 mg/kg
Subject Tadalafil Small molecule 0.5 mg/kg
Subject Tadalafil Small molecule 1 mg/kg