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

NCT ID: NCT00640315

Last Updated: 2016-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-09-30

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.

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease; COPD; Pulmonary hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Riociguat (Adempas, BAY63-2521) 1.0 mg

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

Group Type: EXPERIMENTAL

Riociguat (Adempas, BAY63-2521) 1.0 mg

Intervention Type: DRUG

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).

Riociguat (Adempas, BAY63-2521) 2.5 mg

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

Group Type: EXPERIMENTAL

Riociguat (Adempas, BAY63-2521) 2.5 mg

Intervention Type: DRUG

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).

Interventions

Riociguat (Adempas, BAY63-2521) 1.0 mg

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 Type: DRUG

Riociguat (Adempas, BAY63-2521) 2.5 mg

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).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Heidelberg, Baden-Wurttemberg, Germany

Löwenstein, Baden-Wurttemberg, Germany

München, Bavaria, Germany

Bad Nauheim, Hesse, Germany

Giessen, Hesse, Germany

Greifswald, Mecklenburg-Vorpommern, Germany

Dresden, Saxony, Germany

Countries

Germany

References

H.-A. Ghofrani, G. Staehler, E. Gruenig, M. Halank, V. Mitrovic, S. Unger, W. Mueck, R. Frey, J. Behr. The Effect Of The Soluble Guanylate Cyclase Stimulator Riociguat On Hemodynamics In Patients With Pulmonary Hypertension Due To Chronic Obstructive Pulmonary Disease. D96 CLINICAL TRIALS AND OUTCOMES IN PULMONARY HYPERTENSION.

Reference Type: RESULT

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

2007-003919-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12915

Identifier Type: -

Identifier Source: org_study_id