MedTrace Logo

Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

NCT02283762 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2020-02-05

Study results available
· View outcomes & findings →

Summary

To investigate if Riociguat is effective in the treatment of systemic sclerosis

Conditions

  • Scleroderma, Systemic

Interventions

DRUG

Riociguat (Adempas, BAY63-2521)

Starting dose 0.5 mg TID, increase by 0.5 mg every 2 weeks until highest possible dose of 2.5 mg TID

DRUG

Placebo

Sham-titration

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-15
Primary Completion
2017-12-15
Completion
2019-03-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02283762 on ClinicalTrials.gov