Trial Condition(s):

Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive

Single dose study in patients with chronic obstructive pulmonary disease (COPD) associated pulmonary hypertension.

Bayer Identifier:

12915

ClinicalTrials.gov Identifier:

NCT00640315

EudraCT Number:

2007-003919-31

Study Completed

Trial Purpose

This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).

Inclusion Criteria
- Patients with pulmonary hypertension due to COPD, undergoing routine invasive measurement of hemodynamic parameters.
 - Catheters for measurement of hemodynamic parameters (PAP [pulmonary artery pressure], PCWP [pulmonary capillary wedge pressure], CO [cardiac output], SBP [systolic blood pressure]) must be in place independent of the trial.
Exclusion Criteria
- Acute exacerbation of COPD,
 - Pre-existing lung disease other than COPD,
 - Acute or severe chronic left heart failure,
 - Severe coronary artery disease,
 - Uncontrolled arterial hypertension;
 - Severe left ventricular hypertrophy,
 - Congenital or acquired valvular or myocardial disease,
 - Systolic blood pressure < 100 mmHg,
 - Heart rate < 55 bpm or >105 bpm,
 - PaO2 (arterial partial oxygen pressure)/FiO2 (fraction of inspired oxygen) < 50 mmHg,
 - PaCO2 (arterial partial pressure of carbon dioxide) > 55 mmHg,
 - Severe hepatic insufficiency,
 - Severe renal insufficiency.

Trial Summary

Enrollment Goal
23
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

Greifswald, Germany, 17475

Status
Terminated
 
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 
Locations

Investigative Site

Löwenstein, Germany, 74245

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
Locations

Investigative Site

Bad Nauheim, Germany, 61231

Status
Completed
 
Locations

Investigative Site

Heidelberg, Germany, 69126

Status
Completed
 

Trial Design