The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Adverse event data will be covered in Adverse events section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
262
BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
Matching Placebo tid orally for 16 weeks
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16
6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.
Time frame: Baseline and week 16
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16
The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80\*(PAPmean - PCWP)/CO
Time frame: Baseline and week 16
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16
N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
Time frame: Baseline and week 16
World Health Organization (WHO) Functional Class - Change From Baseline to Week 16
The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.
Time frame: Baseline and week 16
Percentage of Participants With Clinical Worsening
The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; rescue endarterectomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH.
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Unnamed facility
La Jolla, California, United States
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Sacramento, California, United States
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Miami, Florida, United States
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Iowa City, Iowa, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dallas, Texas, United States
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Corrientes, Argentina
...and 79 more locations
Time frame: At week 16
Borg CR 10 Scale - Change From Baseline to Week 16
The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").
Time frame: Baseline and week 16
EQ-5D Utility Score - Change From Baseline to Week 16
EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).
Time frame: Baseline and week 16
Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16
The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).
Time frame: Baseline and week 16