Riociguat for Sarcoidosis Associated Pulmonary Hypertension — RioSAPH  

Sarcoidosis Clinical Trial

Official title: A Double Blind, Placebo Controlled Trial of Oral Riociguat for Sarcoidosis Associated Pulmonary Hypertension

Status Recruiting

Clinical Trial Summary

Double blind placebo controlled trial of riociguat for sarcoidosis associated pulmonary hypertension

Clinical Trial Description

Study design Patients will be recruited into double blind randomized trial of riociguat with 1:1 active drug to placebo. The table below summarizes the study design. Patients will have previously undergone right heart catheterization (RHC) within six months of initial dose dispensation and with no significant change in treatment for pulmonary hypertension. Patients will initiated on 0.5 mg tid and titrated every 2 weeks to a maximum of 2.5 mg three times a day.

The patient will be treated for 48 weeks or until clinical worsening of disease. An adjudication committee will review all cases of clinical worsening. This committee will be blinded to treatment. The determination by the adjudication committee will be used as the final determinant for the primary end point. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Sarcoidosis

• NCT number: NCT02625558
• Study type: Interventional
• Source: University of Cincinnati
• Contact: Robert P Baughman, MD
• Phone: 513-584-5225
• Email: bob.baughman@uc.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2015
• Completion date: October 2018