check_circleStudy Completed

Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive

Bayer Identifier:

12915

ClinicalTrials.gov Identifier:

NCT00640315

EudraCT Number:

2007-003919-31

EU CT Number:

Not Available
Single dose study in patients with chronic obstructive pulmonary disease (COPD) associated pulmonary hypertension.

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.
  • - 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 summary

Enrollment Goal
23
Trial Dates
August 2008 - September 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Greifswald, 17475, Germany
Completed
Gießen, 35392, Germany
Completed
Löwenstein, 74245, Germany
Completed
Dresden, 01307, Germany
Completed
München, 81377, Germany
Completed
Bad Nauheim, 61231, Germany
Completed
Heidelberg, 69126, Germany

Primary Outcome

  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of mean pulmonary artery pressure (PAPmean)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of pulmonary vascular resistance (PVR)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration versus time curve from zero to infinity (AUC) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration versus time curve from zero to infinity divided by dose (AUC/D) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration versus time curve from zero to infinity divided by dose per kg body weight (AUCnorm) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration in plasma (Cmax) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration in plasma divided by dose (Cmax/D) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration in plasma divided by dose per kg body weight (Cmax,norm) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of mean right atrial pressure (RAPmean)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of systolic pulmonary artery pressure (PAPsyst)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of diastolic pulmonary artery pressure (PAPdiast)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of pulmonary capillary wedge pressure (PCWP)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of heart rate (HR)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of systolic blood pressure (SBP)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of diastolic blood pressure (DBP)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of mean arterial pressure (MAP)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of cardiac output (CO)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of pulmonary vascular resistance index (PVRI)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of systemic vascular resistance (SVR)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of systemic vascular resistance index (SVRI)
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of cardiac index
    date_rangeTime Frame:
    From baseline up to 4 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Blood gas analysis - Percentage change from baseline at 2 hours post dose of arterial partial oxygen pressure (PaO2)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Blood gas analysis - Percentage change from baseline at 2 hours post dose of arterial partial pressure of carbon dioxide (PaCO2)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Blood gas analysis - Percentage change from baseline at 2 hours post dose of venous oxygen pressure (PvO2)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Blood gas analysis - Percentage change from baseline at 2 hours post dose of arterial oxygen saturation (SaO2)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Blood gas analysis - Percentage change from baseline at 2 hours post dose of venous oxygen saturation (SvO2)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of forced expiratory volume in 1 second (FEV1)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted FEV1
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of forced vital capacity (FVC)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted FVC
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of FEV1/FVC
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of total lung capacity (TLC)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted TLC
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of residual volume (RV)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted RV
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of maximal expiratory flow at 75% of expiratory vital capacity (MEF75)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of maximal expiratory flow at 50% of expiratory vital capacity (MEF50)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of maximal expiratory flow at 25% of expiratory vital capacity (MEF25)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of total airway resistance (Raw)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of vital capacity (VC)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted VC
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of diffusing capacity of the lung for carbon monoxide (DLCO)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of total lung capacity at the time when the DLCO is measured (alveolar volume, VA)
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Lung function - Percentage change from baseline at 2 hours post dose of specific diffusing capacity
    date_rangeTime Frame:
    Baseline and 2 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of total ventilation (V)
    date_rangeTime Frame:
    Baseline and 1 hour post dose
    enhanced_encryption
    Safety Issue:
    No
  • Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of total perfusion (Q)
    date_rangeTime Frame:
    Baseline and 1 hour post dose
    enhanced_encryption
    Safety Issue:
    No
  • Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of dead space ventilation
    date_rangeTime Frame:
    Baseline and 1 hour post dose
    enhanced_encryption
    Safety Issue:
    No
  • Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of low V/Q perfusion
    date_rangeTime Frame:
    Baseline and 1 hour post dose
    enhanced_encryption
    Safety Issue:
    No
  • Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of normal V/Q perfusion
    date_rangeTime Frame:
    Baseline and 1 hour post dose
    enhanced_encryption
    Safety Issue:
    No
  • Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hours post dose of ventilation-perfusion distribution presented as standard deviation (SD) of perfusion
    date_rangeTime Frame:
    Baseline and 1 hour post dose
    enhanced_encryption
    Safety Issue:
    No
  • Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of ventilation-perfusion distribution presented as standard deviation (SD) of ventilation
    date_rangeTime Frame:
    Baseline and 1 hour post dose
    enhanced_encryption
    Safety Issue:
    No
  • Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of intrapulmonary shunt flow
    date_rangeTime Frame:
    Baseline and 1 hour post dose
    enhanced_encryption
    Safety Issue:
    No
  • Time to reach maximum drug concentration in plasma (tmax) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Half-life associated with the terminal slope (t1/2) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Mean residence time (MRT) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration verse time curve from zero to the last data point (AUC0-tn) of riociguat and metabolite M1 after single dose of riociguat
    date_rangeTime Frame:
    Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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