Conditions: Hypertension, Pulmonary Pulmonary Disease, Chronic Obstructive
Keywords: Chronic obstructive pulmonary disease COPD Pulmonary hypertension
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

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 pulmonary disease (COPD).

Detailed description:
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.

Arms:
arm 1: Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3. arm 2: Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) 1.0 mg intervention 2: Riociguat (Adempas, BAY63-2521) 2.5 mg
Intervention descriptions: intervention 1: 1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3). intervention 2: 2.5 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).

Protocol document: