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: 10 December 2019
• Main ID: EUCTR2008-003539-19-BE
• Date of registration: 23/01/2009
• 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2
• Date of first enrolment: 05/03/2009
• Target sample size: 270
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003539-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; 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; Number of treatment arms in the trial: 1
• 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, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Bayer Clin.Trials Contact CTP Team
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clin.Trials Contact CTP Team
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

Inclusion criteria:
Patients who have completed 16 weeks of treatment in the double blind trial CHEST-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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion criteria:
Patient’s participating in another clinical trial

Patients who have an ongoing serious adverse event from CHEST 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 women with childbearing potential not using a combination of safe contraception methods throughout the study.

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 CHEST-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

Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 18.0 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 100000004855

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

Intervention(s)

Trade Name: Adempas
Product Name: BAY 63-2521 coated 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: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Trade Name: Adempas
Product Name: BAY 63-2521 coated 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: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: Adempas
Product Name: BAY 63-2521 coated 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: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-

Trade Name: Adempas
Product Name: BAY 63-2521 coated 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: RIOCIGUAT
Concentration unit: mg milligram(s)

Primary Outcome(s)

Primary end point(s): The aim of this long-term extension study is primarily safety and tolerability, so no single primary variable has been identified.

Secondary Objective: Not applicable

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

Main Objective: Long-term safety and tolerability of BAY 63-2521 in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or recurrent or persisting pulmonary hypertension after surgical treatment.

Secondary Outcome(s)

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

Secondary end point(s): -Change from baseline in 6 Minute Walking Distance
-Change from baseline in WHO functional class
-Time To Clinical Worsening

Secondary ID(s)

2008-003539-19-DE

BAY63-2521/11349

Source(s) of Monetary Support

Bayer HealthCare AG

Ethics review

Status: Approved
Approval date:
Contact: