Status:
COMPLETED
Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
In addition to the pharmacodynamic and pharmacokinetic variables, the following laboratory variables were assessed: * Hematology: Leucocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular vo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00640315
Start Date
August 1 2008
End Date
September 1 2009
Last Update
December 28 2016
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Heidelberg, Baden-Wurttemberg, Germany, 69126
2
Löwenstein, Baden-Wurttemberg, Germany, 74245
3
München, Bavaria, Germany, 81377
4
Bad Nauheim, Hesse, Germany, 61231