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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00810693




Registration number
NCT00810693
Ethics application status
Date submitted
17/12/2008
Date registered
18/12/2008
Date last updated
22/11/2023

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
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 Symptomatic Pulmonary Arterial Hypertension (PAH)
Secondary ID [1] 0 0
2008-003482-68
Secondary ID [2] 0 0
12934
Universal Trial Number (UTN)
Trial acronym
PATENT-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 - Riociguat (Adempas, BAY63-2521)
Treatment: Drugs - Placebo

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

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

Placebo comparator: Placebo - Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks


Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks

Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks

Treatment: Drugs: Placebo
Matching Placebo tid orally for 12 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 12
Timepoint [1] 0 0
Baseline and week 12
Secondary outcome [1] 0 0
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12
Timepoint [1] 0 0
Baseline and week 12
Secondary outcome [2] 0 0
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12
Timepoint [2] 0 0
Baseline and week 12
Secondary outcome [3] 0 0
World Health Organization (WHO) Functional Class - Change From Baseline to Week 12
Timepoint [3] 0 0
Baseline and week 12
Secondary outcome [4] 0 0
Percentage of Participants With Clinical Worsening
Timepoint [4] 0 0
At week 12
Secondary outcome [5] 0 0
Borg CR 10 Scale - Change From Baseline to Week 12
Timepoint [5] 0 0
Baseline and week 12
Secondary outcome [6] 0 0
EQ-5D Utility Score - Change From Baseline to Week 12
Timepoint [6] 0 0
Baseline and week 12
Secondary outcome [7] 0 0
Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12
Timepoint [7] 0 0
Baseline and week 12

Eligibility
Key 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.).
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 of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.

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
17/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/05/2012
Sample size
Target
Accrual to date
Final
445
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- New Lambton Heights
Recruitment hospital [3] 0 0
- Auchenflower
Recruitment hospital [4] 0 0
- Herston
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3181 - Prahran
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Kentucky
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Massachusetts
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Nebraska
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New York
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Ohio
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Rhode Island
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Texas
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Argentina
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Capital Federal
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Austria
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Oberösterreich
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Austria
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Innsbruck
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Austria
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Wien
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Belgium
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Bruxelles - Brussel
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Belgium
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Leuven
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Brazil
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Rio Grande Do Sul
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Sao Paulo
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Brazil
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Rio de Janeiro
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Beijing
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Praha 2
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Besancon
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Rouen
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Barcelona
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Sevilla
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Cambridgeshire
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West Dunbartonshire
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00810693