A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension

Update Il y a 4 ans
Reference: EUCTR2006-002235-25

Woman and Man

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Extract

To assess the efficacy of 16 weeks of chronic treatment with oral sildenafil in pediatric subjects, aged 1 to 17 years, with PAH. Primary efficacy will be measured by exercise tolerance, bicycle ergometry testing in those subjects who are developmentally able to perform the exercise paradigm as described in the protocol. Secondary efficacy will be assessed in all subjects as described in Section 6.4.1.2 of the protocol.


Inclusion criteria

  • pulmonary arterial hypertension