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Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)

NCT02138825 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2017-12-04

Study results available
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Summary

To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).

Conditions

  • Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary

Interventions

DRUG

Riociguat (Adempas, BAY63-2521)

Active drug 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration. The starting dose will be 0.5 mg TID, and the dose will be adjusted every two weeks for ten weeks in 0.5 mg increments up to a maximum dose of 2.5 mg TID based on patient's systolic blood pressure and well-being.

DRUG

Placebo

Inactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-04
Primary Completion
2016-05-05
Completion
2016-09-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Colombia
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • New Zealand
  • Portugal
  • Russia
  • Saudi Arabia
  • Spain
  • 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 NCT02138825 on ClinicalTrials.gov