NCT02891850

Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients

Detailed description

Data from a previous single arm study (RESPITE) indicate that transition from PDE5i to riociguat may be feasible, safe and beneficial in patients not adequately responding to PDE5i. REPLACE is a randomized controlled study to confirm the potential clinical benefit of transition from PDE5i to riociguat. Satisfactory clinical response in patients who are on a stable dose of phosphodiesterase-5inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal will be compared between one group of patients randomized to maintain current treatment and another group where the PDE5i is replaced by riociguat.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Riociguat (Adempas, BAY63-2521)	Film-coated tablets will be used in this study at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg. Tablets will be administered orally.The starting dose is 1 mg TID; the intervals between drug intakes should be 6 to 8 hours. The dosage should be increased by 0.5 mg increments in 2 week intervals to 1.5 mg, 2.0 mg, and 2.5 mg TID (maximal total daily dose).
DRUG	Sildenafil	Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.
DRUG	Tadalafil	Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.

Timeline

• Start date: 2017-01-11
• Primary completion: 2020-01-29
• Completion: 2020-03-03
• First posted: 2016-09-08
• Last updated: 2021-02-26
• Results posted: 2021-01-22

Locations

81 sites across 21 countries: United States, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom