Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses

• Register: EUCTR
• Last refreshed on: 29 April 2020
• Main ID: EUCTR2008-003610-94-DE
• Date of registration: 31/10/2008
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses
• Scientific title: Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study
• Date of first enrolment: 26/11/2008
• Target sample size: 462
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003610-94
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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, United States

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

Inclusion criteria:
• Patients who have completed 12 weeks of treatment in the double blind trial
PATENT-1.
• Patients must have given their written informed consent to participate in the
study after having received adequate previous information and prior to any
study-specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Patient’s participating in another clinical trial
•Patients who have an ongoing serious adverse event from PATENT-1 that is
assessed as related to BAY 63-2521 are not allowed to participate in the
extension trial.
• Pregnant women(i.e. positive serum ß-human-chorionic-gonadotropin test or other signs of pregnancy) or breast feeding women, or or women with childbearing potential not using a combination of safe contraception methods
• Patients with a medical disorder, condition, or history of such that would impair
the patient's ability to participate or complete this study in the opinion of the
investigator or the sponsor.
• Pertinent non compliance with the conditions for the trial or instructions by the investigator during PATENT-1 participation.
• Patients with hypersensitivity to the investigational drug or inactive
constituents.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension (PAH)
MedDRA version: 15.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-

Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Product Name: BAY 63-2521 tablets 2.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
C

Primary Outcome(s)

Primary end point(s): Safety (adverse events collection) and tolerability will be assessed in the long term treatment (until end of trial)

Secondary Objective:

Timepoint(s) of evaluation of this end point: Until end of the trial

Main Objective: to evaluate the long-term safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in in treatment naive patients and patients pretreated with an Endothelin Receptor Antagonist or a Prostacyclinanalogue with symptomatic Pulmonary Arterial Hypertension (PAH)

Secondary Outcome(s)

Secondary end point(s): To provide an indication of maintenance of efficcacy with long term tretatment the following assessment are included:
- change from baseline in 6 Minute walking distance
- change from baseline in NT-proBNP
- change from baseline in WHO functional class
- Time to Clincal Worsening
- change from baseline in Borg CR10 Scale
- change from baseline in EQ-5D questionnarie
- change from baseline in LPH questionnarie
Additional HEOR endpoints:
- change in use of healthcare resources

Timepoint(s) of evaluation of this end point: Until end of the trial

Secondary ID(s)

BAY63-2521/12935

Source(s) of Monetary Support

Bayer HealthCare AG

Ethics review

Status: Approved
Approval date: 26/11/2008
Contact: