NCT02625558

Riociguat for Sarcoidosis Associated Pulmonary Hypertension

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Sarcoidosis

Interventions

Type	Name	Description
DRUG	Riociguat	Patients will initiated on 0.5 mg tid and titrated every 2 weeks to a maximum of 2.5 mg three times a day
DRUG	Placebo	Placebo given three times a day

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-04-01
• Completion: 2018-10-01
• First posted: 2015-12-09
• Last updated: 2015-12-09

Locations

1 site across 1 country: United States