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Trial record 1 of 1 for:    NCT00810693
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A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) (PATENT-1)

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ClinicalTrials.gov Identifier: NCT00810693
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : February 26, 2014
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Riociguat (Adempas, BAY63-2521) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)
Study Start Date : December 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

Arms and Interventions
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Arm Intervention/treatment
Experimental: Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
 Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Experimental: Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT
Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
 Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
Placebo Comparator: Placebo
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
 Drug: Placebo
Matching Placebo tid orally for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ]
    6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.


Secondary Outcome Measures :
  1. Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ]
    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

  2. N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ]
    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.

  3. World Health Organization (WHO) Functional Class - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ]
    The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants 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.

  4. Percentage of Participants With Clinical Worsening [ Time Frame: At week 12 ]
    The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; 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 .

  5. Borg CR 10 Scale - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ]
    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").

  6. EQ-5D Utility Score - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ]
    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).

  7. Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ]
    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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
  • Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).

Exclusion Criteria:

  • All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810693


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00810693    
Other Study ID Numbers: 12934
2008-003482-68 ( EudraCT Number )
First Posted: December 18, 2008    Key Record Dates
Results First Posted: February 26, 2014
Last Update Posted: November 28, 2016
Last Verified: October 2016
Keywords provided by Bayer:
Pulmonary arterial hypertension
PH
Stimulator
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Lung Diseases
Respiratory Tract Diseases
Riociguat
Enzyme Activators
Molecular Mechanisms of Pharmacological Action