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Single dose study in patients with chronic obstructive pulmonary disease (COPD) associated pulmonary hypertension.
 
 
 
Trial ID: 12915
 
 
 
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY 63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).
 
 
 
Indication/Disease: Hypertension, Pulmonary
Pulmonary Disease, Chronic Obstructive
 
 
 
Status: Completed
Trial Start Date:2008-08-22
 
 
 
Phase: Phase I/II
 
 
 
Trial Type: Interventional
Purpose:Treatment, Allocation: Non-randomized, Masking: Double Blind, Control: Uncontrolled, Assignment: Single Group Assignment, Number of arms:1, Number of participants: 23
 
 
 
Trial Purpose: Safety/Efficacy Study
 
 
 
Product: Riociguat (BAY63-2521)
 
 
 
Intervention Type: Drug
 
 
 
Sponsor: Bayer HealthCare AG
 
 
 
Countries:
GermanyCompleted
 
 
 
Key Eligibility
Criteria:
Healthy Volunteers: No
Gender :Both
Minimum Age :18 Years
Maximum Age :N/A

Other inclusion / exclusion criteria may apply.

 
 
 
Primary outcomes:
  • Impact of a single dose of BAY 63-2521 on pharmacodynamic parameters of the pulmonary system.

 
 
 
Secondary outcomes:

     
     
     
    Results/Links
     
     
     
    This information is provided under Bayer Healthcare's for Publication of Clinical Trial Information. Please refer to the Read This First section. © 2006 Bayer HealthCare
     
     
     
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