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

Primary Purpose

Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Riociguat (Adempas, BAY63-2521) 1.0 mg
Riociguat (Adempas, BAY63-2521) 2.5 mg
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Chronic obstructive pulmonary disease, COPD, Pulmonary hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Riociguat (Adempas, BAY63-2521) 1.0 mg

Riociguat (Adempas, BAY63-2521) 2.5 mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)
PAPmean was reported during right heart catheterization
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)
PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat
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
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
Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat
Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat
Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Riociguat and Metabolite M1 After Single Dose of Riociguat

Secondary Outcome Measures

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)
RAPmean was reported during right heart catheterization
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)
PAPsyst was acquired during right heart catheterization
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)
PAPdiast was acquired during right heart catheterization
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)
PCWP was acquired during right heart catheterization
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)
HR was acquired during right heart catheterization
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Blood Pressure (SBP)
Systolic arterial blood pressure was acquired during right heart catheterization.
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Blood Pressure (DBP)
Diastolic arterial blood pressure was acquired during right heart catheterization.
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Arterial Pressure (MAP)
MAP was acquired during right heart catheterization
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)
CO was measured in triplicate by the thermodilution technique
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance Index (PVRI)
PVRI was calculated as PVRI = (80*(PAPmean - PCWP)/CO)*body surface area
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance (SVR)
SVR was calculated as SVR = 80*(MAP-RAPmean)/CO
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance Index (SVRI)
SVRI was calculated as SVRI = (80*(MAP - RAPmean)/CO)*body surface area
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index
Cardiac index was calculated as cardiac index = CO / body surface area.
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Oxygen Pressure (PaO2)
Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Pressure (PvO2)
Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Oxygen Saturation (SaO2)
Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Saturation (SvO2)
Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Expiratory Volume in 1 Second (FEV1)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC
The percent of predicted TLC was provided by investigator at site.
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 75% of Expiratory Vital Capacity (MEF75)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 50% of Expiratory Vital Capacity (MEF50)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 25% of Expiratory Vital Capacity (MEF25)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
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)
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity
Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Ventilation (V)
Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Perfusion (Q)
Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Dead Space Ventilation
Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Low V/Q Perfusion
Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Normal V/Q Perfusion
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
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
Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Intrapulmonary Shunt Flow
Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat
Half-life Associated With the Terminal Slope (t1/2) of Riociguat and Metabolite M1 After Single Dose of Riociguat
Mean Residence Time (MRT) of Riociguat and Metabolite M1 After Single Dose of Riociguat
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

Full Information

First Posted
February 29, 2008
Last Updated
November 4, 2016
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00640315
Brief Title
Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
Keywords
Chronic obstructive pulmonary disease, COPD, Pulmonary hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Riociguat (Adempas, BAY63-2521) 1.0 mg
Arm Type
Experimental
Arm Description
Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
Arm Title
Riociguat (Adempas, BAY63-2521) 2.5 mg
Arm Type
Experimental
Arm Description
Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
Intervention Type
Drug
Intervention Name(s)
Riociguat (Adempas, BAY63-2521) 1.0 mg
Intervention Description
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
Intervention Name(s)
Riociguat (Adempas, BAY63-2521) 2.5 mg
Intervention Description
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).
Primary Outcome Measure Information:
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)
Description
PAPmean was reported during right heart catheterization
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)
Description
PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output
Time Frame
From baseline up to 4 hours after administration
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)
Description
RAPmean was reported during right heart catheterization
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)
Description
PAPsyst was acquired during right heart catheterization
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)
Description
PAPdiast was acquired during right heart catheterization
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)
Description
PCWP was acquired during right heart catheterization
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)
Description
HR was acquired during right heart catheterization
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Blood Pressure (SBP)
Description
Systolic arterial blood pressure was acquired during right heart catheterization.
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Blood Pressure (DBP)
Description
Diastolic arterial blood pressure was acquired during right heart catheterization.
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Arterial Pressure (MAP)
Description
MAP was acquired during right heart catheterization
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)
Description
CO was measured in triplicate by the thermodilution technique
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance Index (PVRI)
Description
PVRI was calculated as PVRI = (80*(PAPmean - PCWP)/CO)*body surface area
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance (SVR)
Description
SVR was calculated as SVR = 80*(MAP-RAPmean)/CO
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance Index (SVRI)
Description
SVRI was calculated as SVRI = (80*(MAP - RAPmean)/CO)*body surface area
Time Frame
From baseline up to 4 hours after administration
Title
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index
Description
Cardiac index was calculated as cardiac index = CO / body surface area.
Time Frame
From baseline up to 4 hours after administration
Title
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Oxygen Pressure (PaO2)
Description
Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Time Frame
Baseline and 2 hours post dose
Title
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Description
Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Time Frame
Baseline and 2 hours post dose
Title
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Pressure (PvO2)
Description
Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Time Frame
Baseline and 2 hours post dose
Title
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Oxygen Saturation (SaO2)
Description
Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Time Frame
Baseline and 2 hours post dose
Title
Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Saturation (SvO2)
Description
Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
Time Frame
Baseline and 2 hours post dose
Title
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
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC
Description
The percent of predicted TLC was provided by investigator at site.
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV
Time Frame
Baseline and 2 hours post dose
Title
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
Title
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
Title
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
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)
Time Frame
Baseline and 2 hours post dose
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC
Time Frame
Baseline and 2 hours post dose
Title
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
Title
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
Title
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity
Time Frame
Baseline and 2 hours post dose
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
Mean PR Duration (PRmean) - Change From Baseline to Day 3
Description
PR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and day 3
Title
Mean QRS Duration (QRSmean) - Change From Baseline to Day 3
Description
QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and day 3
Title
Mean QT Duration (QTmean) - Change From Baseline to Day 3
Description
QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and day 3
Title
Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Day 3
Description
Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and day 3
Title
Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Day 3
Description
Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69126
Country
Germany
City
Löwenstein
State/Province
Baden-Württemberg
ZIP/Postal Code
74245
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

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

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