Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study

Summary

The objectives of this study are to evaluate the safety of RT234 and the effects of RT234 on exercise capacity as assessed by Cardiopulmonary Exercise Testing (CPET) and six minute walk testing (6MWT) as well as exertional symptoms in patients with pulmonary arterial hypertension (PAH).

Timeline

Start

2020-09-25

Primary completion

2024-11-20

Completion

2025-01-07

Outcome

Mixed primary results

registry analysis (superiority test); RT234 2.0 mg Dose Cohort; p = 0.0204; Mean Difference (Net) 0.55 (95% CI 0.10 to 1.00); t-test, 2 sided NCT04266197 ↗

registry analysis (superiority test); RT234 0.5 mg Dose Cohort; p = 0.7929; Mean Difference (Net) 0.22 (95% CI -1.96 to 2.40); t-test, 2 sided NCT04266197 ↗

registry analysis (superiority test); RT234 2.0 mg Dose Cohort; p = 0.0276; Median Difference (Net) 0.45; Wilcoxon Signed Rank NCT04266197 ↗

registry analysis (superiority test); RT234 0.5 mg Dose Cohort; p = 1.0000; Median Difference (Net) -0.80; Wilcoxon Signed Rank NCT04266197 ↗

Publications

• Background Benza RL, Franco V, Aras MA, Spikes L, Grinnan D, Satler C. Safety and efficacy of RT234 vardenafil inhalation powder on exercise parameters in pulmonary arterial hypertension: phase II, dose-escalation study design. Respir Res. 2022 Dec 17;23(1):355. doi: 10.1186/s12931-022-02262-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vardenafil	Small molecule	0.5 mg	Inhaled
Subject	Vardenafil	Small molecule	1 mg	Inhaled
Subject	Vardenafil	Small molecule	2 mg	Inhaled

Indications