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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00855465




Registration number
NCT00855465
Ethics application status
Date submitted
15/12/2008
Date registered
4/03/2009
Date last updated
21/11/2023

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
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

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
Timepoint [1] 0 0
Baseline and week 16
Secondary outcome [1] 0 0
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16
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
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
Timepoint [3] 0 0
Baseline and week 16
Secondary outcome [4] 0 0
Percentage of Participants With Clinical Worsening
Timepoint [4] 0 0
At week 16
Secondary outcome [5] 0 0
Borg CR 10 Scale - Change From Baseline to Week 16
Timepoint [5] 0 0
Baseline and week 16
Secondary outcome [6] 0 0
EQ-5D Utility Score - Change From Baseline to Week 16
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
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
Sex
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
23/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/06/2012
Sample size
Target
Accrual to date
Final
262
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Corrientes
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Austria
State/province [10] 0 0
Wien
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles - Brussel
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio Grande Do Sul
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio de Janeiro
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
China
State/province [19] 0 0
Shandong
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Shanghai
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 2
Country [23] 0 0
Denmark
State/province [23] 0 0
Aarhus N
Country [24] 0 0
France
State/province [24] 0 0
Brest
Country [25] 0 0
France
State/province [25] 0 0
Caen
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France
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Clamart Cedex
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France
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Lille Cedex
Country [28] 0 0
France
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Nice
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France
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Pessac
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France
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Rouen
Country [31] 0 0
France
State/province [31] 0 0
Vandoeuvre Les Nancy
Country [32] 0 0
Germany
State/province [32] 0 0
Baden-Württemberg
Country [33] 0 0
Germany
State/province [33] 0 0
Bayern
Country [34] 0 0
Germany
State/province [34] 0 0
Hessen
Country [35] 0 0
Germany
State/province [35] 0 0
Mecklenburg-Vorpommern
Country [36] 0 0
Germany
State/province [36] 0 0
Niedersachsen
Country [37] 0 0
Germany
State/province [37] 0 0
Nordrhein-Westfalen
Country [38] 0 0
Germany
State/province [38] 0 0
Saarland
Country [39] 0 0
Germany
State/province [39] 0 0
Sachsen
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Germany
State/province [40] 0 0
Hamburg
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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
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Kanagawa
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Japan
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Miyagi
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Japan
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Nagano
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Japan
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Osaka
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Japan
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Tokyo
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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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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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Poland
State/province [56] 0 0
Krakow
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Poland
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Otwock
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Portugal
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Coimbra
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Novosibirsk
Country [60] 0 0
Russian Federation
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St. Petersburg
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Slovakia
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Bratislava 37
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Spain
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Barcelona
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Spain
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Madrid
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Switzerland
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Zürich
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Taiwan
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Taipei
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Turkey
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Ankara
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Turkey
State/province [67] 0 0
Istanbul
Country [68] 0 0
Turkey
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Izmir
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Cambridgeshire
Country [70] 0 0
United Kingdom
State/province [70] 0 0
West Dunbartonshire
Country [71] 0 0
United Kingdom
State/province [71] 0 0
London

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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00855465