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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00810693
First received: December 17, 2008
Last updated: January 24, 2014
Last verified: January 2014

December 17, 2008
January 24, 2014
December 2008
May 2012   (final data collection date for primary outcome measure)
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.
6 minute Walking Distance [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00810693 on ClinicalTrials.gov Archive Site
  • Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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
  • N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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.
  • World Health Organization (WHO) Functional Class - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With Clinical Worsening [ Time Frame: At week 12 ] [ Designated as safety issue: No ]
    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 .
  • Borg CR 10 Scale - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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").
  • EQ-5D Utility Score - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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).
  • Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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).
  • Change from baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in NT-pro BNP [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in WHO functional class [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Time To Clinical Worsening [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Borg Dyspnoea Score [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in EQ-5D visual analogue scale [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Health Economics questionnaries [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
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)

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Hypertension
  • Drug: Riociguat (Adempas, BAY63-2521)
    BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
  • Drug: Riociguat (Adempas, BAY63-2521)
    BAY63-2521: 1.5mg tid orally for 12 weeks
  • Drug: Placebo
    Matching Placebo tid orally for 12 weeks
  • 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
    Intervention: Drug: Riociguat (Adempas, BAY63-2521)
  • 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
    Intervention: Drug: Riociguat (Adempas, BAY63-2521)
  • Placebo Comparator: Placebo
    Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
445
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT00810693
12934, 2008-003482-68
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP