When the pulmonary arteries become narrower or obstructed, then the condition is known as Pulmonary Hypertension. Due to this condition, right ventricle of the heart is in lot of pressure to work hardly to pump blood leading to weakening and organ enlargement. When it is present in newborn babies, it is called as Persistent Pulmonary Hypertension of Newborn or neonatal pulmonary hypertension.
As per the Pfizer, Inc. announcement, a phase 3 trial was conducted to study the safety and efficacy of intravenous Sildenafil. When added to Nitric Oxide; which is inhaled for the treatment of newborns with Persistent Pulmonary Hypertension, Sildenafil did not attain its primary efficacy endpoint.
This study had two consecutive parts. Part A consisted of randomized, placebo-controlled, double-blind interventional phase to examine safety and efficacy. Part B is the non-interventional phase with a follow-up at 12 and 24 months after the end of study treatment for evaluating developmental progress. The result obtained is solely based on the observation from Part A of the study; Part B is ongoing.
The profile of safety and adverse events observed in this study was comparable to the known safety profile of Revatio in earlier studies in pediatric and adult patients with pulmonary arterial hypertension taking Revatio.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
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