Trial Condition(s):

Pharmacology, clinical

BAY63-2521, POC SD invasive hemodynamics in patient with PH

Bayer Identifier:

11874

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2005-002522-64

Study Completed

Trial Purpose

Primary objective: To investigate the safety, tolerability, pharmacokinetics, impact on pulmonary and systemic hemodynamics, and gas exchange of BAY 63-2521.
Study Part A: Individual dose titration of 3 single doses of BAY 63-2521 solution was performed.
Study Part B: Single dose of BAY 63-2521 solution was tested.

Inclusion Criteria
- Subjects 18 - 80 years of age with suspected pulmonary hypertension due to pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, or interstitial lung disease.
Exclusion Criteria
- Certain pre-existing lung disease
 - Certain pre-existing cardiovascular disorders
 - PaO2/FiO2 <50 mmHg
 - PaCO2 >55 mmHg
 - Deficiencies of blood coagulation, inherited or acquired blood coagulation disorders
 - Disseminated intravascular coagulation
 - Deficient platelet function, thrombocytopenia
 - Evidence for major bleeding or intracranial hemorrhage
 - Latent bleeding risk such as diabetic retinopathy, history of gastrointestinal bleeding, colitis ulcerosa
 - Severe hepatic insufficiency
 - Renal insufficiency
 - Primary or secondary immunodeficiencies
 - Previous therapeutic radiation of lungs or mediastinum
 - Concomitant medication not allowed
 - Elevated intracranial pressure
 - Women with childbearing potential without reliable contraceptive measures, pregnancy, breast feeding
 - Subjects whose underlying disease was unlikely to permit them to survive the study
 - Sickle cell anemia

Trial Summary

Enrollment Goal
19
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 

Trial Design