check_circleStudy Completed

Hypertension, Pulmonary

Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH)

Trial purpose

The purpose of this study is to assess multiple ascending doses of a new drug (BAY63-2521) given orally, to evaluate if it is safe and can help to improve the well-being, symptoms (e.g. disturbed breathing) and outcome of pulmonary hypertension associated with lung fibrosis. Patients living with pulmonary hypertension associated with interstitial lung disease have a risk of increased number of hospitalisations because of worsening of their condition. Until now there is no approved medication for this disease. The current treatment of pulmonary hypertension associated with interstitial lung disease consists: of oxygen and medical treatment with vasodilators, e.g. so-called Calcium-antagonists. Therefore, there is a need for new drugs in the treatment of pulmonary hypertension associated with interstitial lung disease.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
22
Trial Dates
August 2008 - July 2025
Phase
Phase 2
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
München, 81377, Germany
Completed
Homburg, 66421, Germany
Completed
Dresden, 1307, Germany
Completed
Hannover, 30625, Germany
Completed
Gießen, 35392, Germany

Primary Outcome

  • Safety and tolerability
    date_rangeTime Frame:
    12 weeks treatment
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Pharmacokinetics
    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014
    date_rangeTime Frame:
    at every study visit except at run-in and Follow-up
    enhanced_encryption
    Safety Issue:
    no
  • 6-Minute Walk Test
    date_rangeTime Frame:
    at every study visit except at Follow-up
    enhanced_encryption
    Safety Issue:
    no
  • Modified borg scale
    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014
    date_rangeTime Frame:
    at every study visit except at Follow-up
    enhanced_encryption
    Safety Issue:
    no
  • Quality of life assessments
    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014
    date_rangeTime Frame:
    at baseline, after 6 weeks, after 12 weeks, Follow-up and at each visit during long term extension phase
    enhanced_encryption
    Safety Issue:
    No
  • Hemodynamic parameters
    date_rangeTime Frame:
    optional after 12weeks
    enhanced_encryption
    Safety Issue:
    No
  • Laboratory Parameters
    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014
    date_rangeTime Frame:
    at each study visit during run-in and treatment phase and long term extension
    enhanced_encryption
    Safety Issue:
    yes
  • Electrocardiogram (ECG)
    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014
    date_rangeTime Frame:
    at each study visit during run-in and treatment phase and long term extension
    enhanced_encryption
    Safety Issue:
    yes
  • Blood pressure and heart rate
    date_rangeTime Frame:
    at each study visit during run-in and treatment phase and long term extension
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A multi-center, non-randomized, non blinded, non-controlled study to investigate the impact of multiple doses of BAY63-2521 on safety, tolerability, pharmacokinetics and pharmacodynamics in patients with interstitial lung disease associated pulmonary hypertension.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1