Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics, Gas Exchange and Lung Function Parameters of a Single-dose of BAY63-2521 IR-tablet in Patients With COPD Associated Pulmonary Hypertension in an Non-randomized, Non-blinded Design
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).
In addition to the pharmacodynamic and pharmacokinetic variables, the following laboratory
variables were assessed:
- Hematology: Leucocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume
(MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration
(MCHC), platelets, white blood cell (WBC), partial thromboplastin time (PTT),
prothrombin time (Quick), international normalized ratio (INR) (prothrombin time
expressed in relation to normal value) ;
- Clinical chemistry: aspartate aminotransferase (AST), alanine aminotransferase (ALT),
alkaline phosphatase (AP), gamma glutamyl transpeptidase (GGT), creatine phosphokinase
(CK), lipase, cholinesterase (CHE), glucose, creatinine, urea, uric acid, bilirubin,
total protein, serum albumin, sodium, potassium, calcium, chloride.
And due to the small number of subjects analyzed at several local labs, no summary
statistics were provided.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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