Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.

Bayer

Status and phase: Completed; Phase 1

Conditions: Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Riociguat (Adempas, BAY63-2521) 1.0 mg; Drug: Riociguat (Adempas, BAY63-2521) 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640315

12915

2007-003919-31 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Riociguat (Adempas, BAY63-2521) 1.0 mg

Experimental group

Description:

Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.

Treatment:

Drug: Riociguat (Adempas, BAY63-2521) 1.0 mg

Riociguat (Adempas, BAY63-2521) 2.5 mg

Experimental group

Description:

Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Treatment:

Drug: Riociguat (Adempas, BAY63-2521) 2.5 mg