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Clinical Trials

McKelvey Research Studies active in 2008

FRESENIUS (formerly Nabi, formerly Enzon): (Emory IRB # 892-2004) EZ-2053-001, “A Double Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study of Acute Pulmonary Allograft Rejection in Adult Recipients of Primary Pulmonary Allograft(s)” PI: Lawrence

LILLY: LVGX(eIRB# 0000986), “A Double-Blind Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension” PI: Lawrence (SH)

ACTELION:COMPASS 3 (eIRB# 00004219): “A Prospective, Open-Label, Multi-Center Study to Evaluate Both the Ability of Treatment Naïve PAH Patients to Achieve a Threshold Six Minute Walk Distance with Either Bosentan Monotherapy or With the Addition of Sildenafil and to Explore the Effects on Cardiac Remodeling” PI: Fisher (JG)

ALNYLAM: RSV study (eIRB #000011404): “A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)” PI: Pelaez (SH)

ACTELION: (eIRB #00012364) AC-055-302: SERAPHIN: Study with Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve clinical outcome. “A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbitity and mortality in patients with symptomatic pulmonary arterial hypertension” PI: Fisher (JG)

ACTELION: (eIRB # 00012365): AC-055-303 OL “Long-term single-arm open-label extension study of the SERAPHIN study, to asses the safety and tolerability of ACT-064992 in patients with symptomatic pulmonary arterial hypertension” PI: FISHER (JG)

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