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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Riociguat

Criteria

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.