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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00640315
First received: February 29, 2008
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: November 7, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypertension, Pulmonary
Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Riociguat (Adempas, BAY63-2521) 1.0 mg
Drug: Riociguat (Adempas, BAY63-2521) 2.5 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Riociguat (Adempas, BAY63-2521) 1.0 mg     Riociguat (Adempas, BAY63-2521) 2.5 mg  
STARTED     10     13  
Participants Received Treatment     10     13  
COMPLETED     10     12  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Riociguat (Adempas, BAY63-2521) 1.0 mg     Riociguat (Adempas, BAY63-2521) 2.5 mg     Total  
Number of Participants  
[units: participants]
  10     13     23  
Age  
[units: Years]
Mean ± Standard Deviation
  67.5  ± 8.9     69.2  ± 5.7     68.4  ± 7.1  
Gender  
[units: Participants]
     
Female     5     6     11  
Male     5     7     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)   [ Time Frame: From baseline up to 4 hours after administration ]

2.  Primary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)   [ Time Frame: From baseline up to 4 hours after administration ]

3.  Primary:   Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat   [ Time 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 ]

4.  Primary:   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   [ Time 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 ]

5.  Primary:   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   [ Time 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 ]

6.  Primary:   Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat   [ Time 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 ]

7.  Primary:   Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat   [ Time 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 ]

8.  Primary:   Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Riociguat and Metabolite M1 After Single Dose of Riociguat   [ Time 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 ]

9.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)   [ Time Frame: From baseline up to 4 hours after administration ]

10.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)   [ Time Frame: From baseline up to 4 hours after administration ]

11.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)   [ Time Frame: From baseline up to 4 hours after administration ]

12.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)   [ Time Frame: From baseline up to 4 hours after administration ]

13.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)   [ Time Frame: From baseline up to 4 hours after administration ]

14.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Blood Pressure (SBP)   [ Time Frame: From baseline up to 4 hours after administration ]

15.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Blood Pressure (DBP)   [ Time Frame: From baseline up to 4 hours after administration ]

16.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Arterial Pressure (MAP)   [ Time Frame: From baseline up to 4 hours after administration ]

17.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)   [ Time Frame: From baseline up to 4 hours after administration ]

18.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance Index (PVRI)   [ Time Frame: From baseline up to 4 hours after administration ]

19.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance (SVR)   [ Time Frame: From baseline up to 4 hours after administration ]

20.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance Index (SVRI)   [ Time Frame: From baseline up to 4 hours after administration ]

21.  Secondary:   Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index   [ Time Frame: From baseline up to 4 hours after administration ]

22.  Secondary:   Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Oxygen Pressure (PaO2)   [ Time Frame: Baseline and 2 hours post dose ]

23.  Secondary:   Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Pressure of Carbon Dioxide (PaCO2)   [ Time Frame: Baseline and 2 hours post dose ]

24.  Secondary:   Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Pressure (PvO2)   [ Time Frame: Baseline and 2 hours post dose ]

25.  Secondary:   Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Oxygen Saturation (SaO2)   [ Time Frame: Baseline and 2 hours post dose ]

26.  Secondary:   Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Saturation (SvO2)   [ Time Frame: Baseline and 2 hours post dose ]

27.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Baseline and 2 hours post dose ]

28.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1   [ Time Frame: Baseline and 2 hours post dose ]

29.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)   [ Time Frame: Baseline and 2 hours post dose ]

30.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC   [ Time Frame: Baseline and 2 hours post dose ]

31.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC   [ Time Frame: Baseline and 2 hours post dose ]

32.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)   [ Time Frame: Baseline and 2 hours post dose ]

33.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC   [ Time Frame: Baseline and 2 hours post dose ]

34.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)   [ Time Frame: Baseline and 2 hours post dose ]

35.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV   [ Time Frame: Baseline and 2 hours post dose ]

36.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 75% of Expiratory Vital Capacity (MEF75)   [ Time Frame: Baseline and 2 hours post dose ]

37.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 50% of Expiratory Vital Capacity (MEF50)   [ Time Frame: Baseline and 2 hours post dose ]

38.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 25% of Expiratory Vital Capacity (MEF25)   [ Time Frame: Baseline and 2 hours post dose ]

39.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)   [ Time Frame: Baseline and 2 hours post dose ]

40.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)   [ Time Frame: Baseline and 2 hours post dose ]

41.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC   [ Time Frame: Baseline and 2 hours post dose ]

42.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)   [ Time Frame: Baseline and 2 hours post dose ]

43.  Secondary:   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)   [ Time Frame: Baseline and 2 hours post dose ]

44.  Secondary:   Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity   [ Time Frame: Baseline and 2 hours post dose ]

45.  Secondary:   Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Ventilation (V)   [ Time Frame: Baseline and 1 hour post dose ]

46.  Secondary:   Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Perfusion (Q)   [ Time Frame: Baseline and 1 hour post dose ]

47.  Secondary:   Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Dead Space Ventilation   [ Time Frame: Baseline and 1 hour post dose ]

48.  Secondary:   Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Low V/Q Perfusion   [ Time Frame: Baseline and 1 hour post dose ]

49.  Secondary:   Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Normal V/Q Perfusion   [ Time Frame: Baseline and 1 hour post dose ]

50.  Secondary:   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   [ Time Frame: Baseline and 1 hour post dose ]

51.  Secondary:   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   [ Time Frame: Baseline and 1 hour post dose ]

52.  Secondary:   Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Intrapulmonary Shunt Flow   [ Time Frame: Baseline and 1 hour post dose ]

53.  Secondary:   Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat   [ Time 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 ]

54.  Secondary:   Half-life Associated With the Terminal Slope (t1/2) of Riociguat and Metabolite M1 After Single Dose of Riociguat   [ Time 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 ]

55.  Secondary:   Mean Residence Time (MRT) of Riociguat and Metabolite M1 After Single Dose of Riociguat   [ Time 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 ]

56.  Secondary:   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   [ Time 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 ]

57.  Other Pre-specified:   Mean PR Duration (PRmean) - Change From Baseline to Day 3   [ Time Frame: Baseline and day 3 ]

58.  Other Pre-specified:   Mean QRS Duration (QRSmean) - Change From Baseline to Day 3   [ Time Frame: Baseline and day 3 ]

59.  Other Pre-specified:   Mean QT Duration (QTmean) - Change From Baseline to Day 3   [ Time Frame: Baseline and day 3 ]

60.  Other Pre-specified:   Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Day 3   [ Time Frame: Baseline and day 3 ]

61.  Other Pre-specified:   Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Day 3   [ Time Frame: Baseline and day 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00640315     History of Changes
Other Study ID Numbers: 12915, 2007-003919-31
Study First Received: February 29, 2008
Results First Received: November 7, 2013
Last Updated: January 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices