Trial Condition(s):

Hypertension, Pulmonary

Interaction study in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg TID

Bayer Identifier:

11917

ClinicalTrials.gov Identifier:

NCT00680654

EudraCT Number:

2008-000914-65

Study Completed

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.

Inclusion Criteria
- Patients with pulmonary hypertension stable for the last 6 weeks
 - Treated with Sildenafil 3 × 20 mg
 - Undergoing routine invasive diagnostics.
Exclusion Criteria
- Pre-existing lung disease other than pulmonary arterial hypertension, 
 - Acute or severe chronic left heart failure, 
 - Severe coronary artery disease, 
 - Uncontrolled arterial hypertension; 
 - Congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension, 
 - Systolic blood pressure < 100 mmHg, heart rate < 55 bpm or >105 bpm, PaO2/FiO2 < 50 mmHg, 
 - PaCO2 > 55 mmHg, 
 - Severe hepatic insufficiency, 
 - Severe renal insufficiency, 
 - Administration of strong CYP3A4 inhibitors or inductors

Trial Summary

Enrollment Goal
7
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 
Locations

Investigative Site

Löwenstein, Germany, 74245

Status
Completed
 
Locations

Investigative Site

Greifswald, Germany, 17475

Status
Terminated
 
Locations

Investigative Site

Heidelberg, Germany, 69126

Status
Terminated
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 

Trial Design