drugset / Trial / NCT00125918
PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
Timeline
- Start
- 2005-08
- Primary completion
- 2007-08
- Completion
- 2007-08
Publications
- Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2022 Feb;61(2):249-262. doi: 10.1007/s40262-021-01052-8. Epub 2021 Aug 11.
- Galie N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tadalafil | Small molecule | 2.5 mg | Oral |
| Comparator | Tadalafil | Small molecule | 10 mg | Oral |
| Comparator | Tadalafil | Small molecule | 20 mg | Oral |
| Comparator | Tadalafil | Small molecule | 40 mg | Oral |