AEs Potentially Associated with QT Prolongation During Double-Blind Period (Studies 1027 and 1028)
•Preclinical testing revealed potential for QT prolongation
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•A previous CCR5 antagonist (“Schering C”) found to cause QT prolongation
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•Thorough QT study for MVC determined to be inadequate
–No significant prolongation with MVC, but control arm was not interpretable
–Attempts to resolve this issue are underway
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•MedDRA terms: Arrhythmia, Palpitations, Syncope, Tachycardia
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•14 patients with potential ventricular events:
–MVC QD 4 (1.0%)
–MVC BID 7 (1.6%)
–Placebo 3 (1.4%)