drugset / Trial / NCT00159874
A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
RandomizedParallel-groupOpen-labelTreatment
Summary
Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.
Timeline
- Start
- 2004-01
- Primary completion
- 2012-12
- Completion
- 2012-12
Publications
- Russell S, Beghetti M, Oudiz R, Balagtas C, Zhang M, Ivy D. Effects of oral sildenafil on exercise capacity in children with pulmonary arterial hypertension: a randomised trial. Open Heart. 2019 Dec 3;6(2):e001149. doi: 10.1136/openhrt-2019-001149. eCollection 2019.
- Chanu P, Gao X, Bruno R, Claret L, Harnisch L. A modeling and simulation-based assessment of the impact of confounding factors on the readout of a sildenafil survival trial in pulmonary arterial hypertension. J Pharmacokinet Pharmacodyn. 2019 Oct;46(5):499-509. doi: 10.1007/s10928-019-09654-3. Epub 2019 Sep 20.
- Barst RJ, Beghetti M, Pulido T, Layton G, Konourina I, Zhang M, Ivy DD; STARTS-2 Investigators. STARTS-2: long-term survival with oral sildenafil monotherapy in treatment-naive pediatric pulmonary arterial hypertension. Circulation. 2014 May 13;129(19):1914-23. doi: 10.1161/CIRCULATIONAHA.113.005698. Epub 2014 Mar 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sildenafil | Unknown | 10 mg | Oral |
| Subject | Sildenafil | Unknown | 20 mg | Oral |
| Subject | Sildenafil | Unknown | 40 mg | Oral |
| Subject | Sildenafil | Unknown | 80 mg | Oral |