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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00855465




Registration number
NCT00855465
Ethics application status
Date submitted
15/12/2008
Date registered
3/03/2009
Date last updated
14/10/2016

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
Scientific 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Secondary ID [1] 0 0
2007-000072-16
Secondary ID [2] 0 0
11348
Universal Trial Number (UTN)
Trial acronym
CHEST-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)
Treatment: Drugs - Placebo

Experimental: Riociguat (Adempas, BAY63-2521)_individual dose titration - 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 16 weeks

Placebo Comparator: Placebo - Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks


Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.

Treatment: Drugs: Placebo
Matching Placebo tid orally for 16 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and week 16
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and week 16
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline and week 16
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline and week 16
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
At week 16
Secondary outcome [5] 0 0
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").
Timepoint [5] 0 0
Baseline and week 16
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
Baseline and week 16
Secondary outcome [7] 0 0
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).
Timepoint [7] 0 0
Baseline and week 16

Eligibility
Key inclusion criteria
- Male and female patients with CTEPH either inoperable or with persistent or recurrent
PH after surgery.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical
Classification of Pulmonary Hypertension.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Auchenflower
Recruitment hospital [3] 0 0
- Chermside
Recruitment hospital [4] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Argentina
State/province [17] 0 0
Ciudad Auton. de Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Capital Federal
Country [19] 0 0
Argentina
State/province [19] 0 0
Corrientes
Country [20] 0 0
Austria
State/province [20] 0 0
Innsbruck
Country [21] 0 0
Austria
State/province [21] 0 0
Wien
Country [22] 0 0
Belgium
State/province [22] 0 0
Bruxelles - Brussel
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande do Sul
Country [25] 0 0
Brazil
State/province [25] 0 0
Sao Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio de Janeiro
Country [27] 0 0
Brazil
State/province [27] 0 0
São Paulo
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
China
State/province [31] 0 0
Shandong
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Shanghai
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Praha 2
Country [35] 0 0
Denmark
State/province [35] 0 0
Aarhus N
Country [36] 0 0
France
State/province [36] 0 0
Besancon
Country [37] 0 0
France
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Brest
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France
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Caen
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France
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Clamart Cedex
Country [40] 0 0
France
State/province [40] 0 0
GRENOBLE Cedex 09
Country [41] 0 0
France
State/province [41] 0 0
Lille Cedex
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France
State/province [42] 0 0
Montpellier
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France
State/province [43] 0 0
Nice
Country [44] 0 0
France
State/province [44] 0 0
Pessac
Country [45] 0 0
France
State/province [45] 0 0
Rouen
Country [46] 0 0
France
State/province [46] 0 0
Tours
Country [47] 0 0
France
State/province [47] 0 0
Vandoeuvre Les Nancy
Country [48] 0 0
Germany
State/province [48] 0 0
Baden-Württemberg
Country [49] 0 0
Germany
State/province [49] 0 0
Bayern
Country [50] 0 0
Germany
State/province [50] 0 0
Hessen
Country [51] 0 0
Germany
State/province [51] 0 0
Mecklenburg-Vorpommern
Country [52] 0 0
Germany
State/province [52] 0 0
Niedersachsen
Country [53] 0 0
Germany
State/province [53] 0 0
Nordrhein-Westfalen
Country [54] 0 0
Germany
State/province [54] 0 0
Saarland
Country [55] 0 0
Germany
State/province [55] 0 0
Sachsen
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Germany
State/province [56] 0 0
Hamburg
Country [57] 0 0
Ireland
State/province [57] 0 0
Dublin
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Israel
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Petah Tikva
Country [59] 0 0
Italy
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Lazio
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Italy
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Lombardia
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Ishikawa
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Japan
State/province [64] 0 0
Kanagawa
Country [65] 0 0
Japan
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Miyagi
Country [66] 0 0
Japan
State/province [66] 0 0
Nagano
Country [67] 0 0
Japan
State/province [67] 0 0
Osaka
Country [68] 0 0
Japan
State/province [68] 0 0
Tokyo
Country [69] 0 0
Japan
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Chiba
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Mexico D.F.
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Mexico
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Querétaro
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Netherlands
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Amsterdam
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Netherlands
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Nieuwegein
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Poland
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Krakow
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Poland
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Otwock
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Poland
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Wroclaw
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Portugal
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Coimbra
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Portugal
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Lisboa
Country [82] 0 0
Portugal
State/province [82] 0 0
Porto
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Novosibirsk
Country [84] 0 0
Russian Federation
State/province [84] 0 0
St. Petersburg
Country [85] 0 0
Slovakia
State/province [85] 0 0
Bratislava 37
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Madrid
Country [88] 0 0
Switzerland
State/province [88] 0 0
Zürich
Country [89] 0 0
Taiwan
State/province [89] 0 0
Kaohsiung
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taipei
Country [91] 0 0
Turkey
State/province [91] 0 0
Ankara
Country [92] 0 0
Turkey
State/province [92] 0 0
Istanbul
Country [93] 0 0
Turkey
State/province [93] 0 0
Izmir
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Cambridgeshire
Country [95] 0 0
United Kingdom
State/province [95] 0 0
West Dunbartonshire
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/show/NCT00855465
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications