check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:
11917
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Interaction study in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg TID
Trial purpose
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.
Key Participants Requirements
Sex
BothAge
18 - 80 YearsTrial summary
Enrollment Goal
7Trial Dates
October 2008 - November 2009Phase
Phase 1Could I Receive a placebo
NoProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Gießen, 35392, Germany | |
Completed | Löwenstein, 74245, Germany | |
Terminated | Greifswald, 17475, Germany | |
Terminated | Heidelberg, 69126, Germany | |
Completed | Dresden, 01307, Germany |
Primary Outcome
- Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.date_rangeTime Frame:At baseline, throughout study days 1 and 2enhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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