- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00640315
Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.
November 4, 2016 updated by: Bayer
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
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).
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69126
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Löwenstein, Baden-Württemberg, Germany, 74245
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Bayern
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München, Bayern, Germany, 81377
-
-
Hessen
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Bad Nauheim, Hessen, Germany, 61231
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Gießen, Hessen, Germany, 35392
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Mecklenburg-Vorpommern
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Greifswald, Mecklenburg-Vorpommern, Germany, 17475
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-
Sachsen
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Dresden, Sachsen, Germany, 01307
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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).
|
Experimental: 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
PAPmean was reported during right heart catheterization
|
From baseline up to 4 hours after administration
|
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
|
PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output
|
From baseline up to 4 hours after administration
|
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
|
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
|
|
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
|
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
|
|
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
|
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
|
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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
|
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
|
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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
|
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
|
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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
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
RAPmean was reported during right heart catheterization
|
From baseline up to 4 hours after administration
|
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
|
PAPsyst was acquired during right heart catheterization
|
From baseline up to 4 hours after administration
|
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
|
PAPdiast was acquired during right heart catheterization
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From baseline up to 4 hours after administration
|
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
|
PCWP was acquired during right heart catheterization
|
From baseline up to 4 hours after administration
|
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)
Time Frame: From baseline up to 4 hours after administration
|
HR was acquired during right heart catheterization
|
From baseline up to 4 hours after administration
|
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
|
Systolic arterial blood pressure was acquired during right heart catheterization.
|
From baseline up to 4 hours after administration
|
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
|
Diastolic arterial blood pressure was acquired during right heart catheterization.
|
From baseline up to 4 hours after administration
|
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
|
MAP was acquired during right heart catheterization
|
From baseline up to 4 hours after administration
|
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)
Time Frame: From baseline up to 4 hours after administration
|
CO was measured in triplicate by the thermodilution technique
|
From baseline up to 4 hours after administration
|
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
|
PVRI was calculated as PVRI = (80*(PAPmean - PCWP)/CO)*body surface area
|
From baseline up to 4 hours after administration
|
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
|
SVR was calculated as SVR = 80*(MAP-RAPmean)/CO
|
From baseline up to 4 hours after administration
|
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
|
SVRI was calculated as SVRI = (80*(MAP - RAPmean)/CO)*body surface area
|
From baseline up to 4 hours after administration
|
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index
Time Frame: From baseline up to 4 hours after administration
|
Cardiac index was calculated as cardiac index = CO / body surface area.
|
From baseline up to 4 hours after administration
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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
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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".
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Baseline and 2 hours post dose
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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
|
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".
|
Baseline and 2 hours post dose
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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
|
Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
|
Baseline and 2 hours post dose
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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
|
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".
|
Baseline and 2 hours post dose
|
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
|
Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".
|
Baseline and 2 hours post dose
|
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
|
Baseline and 2 hours post dose
|
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Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
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Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
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Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
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Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
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Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
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Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC
Time Frame: Baseline and 2 hours post dose
|
The percent of predicted TLC was provided by investigator at site.
|
Baseline and 2 hours post dose
|
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
|
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
|
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
|
Baseline and 2 hours post dose
|
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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
|
Baseline and 2 hours post dose
|
|
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
|
Baseline and 2 hours post dose
|
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Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
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Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
|
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
|
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
|
Baseline and 2 hours post dose
|
|
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
|
Baseline and 2 hours post dose
|
|
Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity
Time Frame: Baseline and 2 hours post dose
|
Baseline and 2 hours post dose
|
|
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
|
Baseline and 1 hour post dose
|
|
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
|
Baseline and 1 hour post dose
|
|
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
|
Baseline and 1 hour post dose
|
|
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
|
Baseline and 1 hour post dose
|
|
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
|
Baseline and 1 hour post dose
|
|
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
|
Baseline and 1 hour post dose
|
|
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
|
Baseline and 1 hour post dose
|
|
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
|
Baseline and 1 hour post dose
|
|
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
|
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
|
|
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
|
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
|
|
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
|
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
|
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean PR Duration (PRmean) - Change From Baseline to Day 3
Time Frame: Baseline and day 3
|
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.
|
Baseline and day 3
|
Mean QRS Duration (QRSmean) - Change From Baseline to Day 3
Time Frame: Baseline and day 3
|
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.
|
Baseline and day 3
|
Mean QT Duration (QTmean) - Change From Baseline to Day 3
Time Frame: Baseline and day 3
|
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.
|
Baseline and day 3
|
Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Day 3
Time Frame: Baseline and day 3
|
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.
|
Baseline and day 3
|
Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Day 3
Time Frame: Baseline and day 3
|
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.
|
Baseline and day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
February 29, 2008
First Submitted That Met QC Criteria
March 20, 2008
First Posted (Estimate)
March 21, 2008
Study Record Updates
Last Update Posted (Estimate)
December 28, 2016
Last Update Submitted That Met QC Criteria
November 4, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12915
- 2007-003919-31 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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