BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT00910429
• Date of registration: 27/05/2009
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension CHEST-2
• Scientific title: Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
• Date of first enrolment: July 1, 2009
• Target sample size: 237
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00910429
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Czechia, 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 Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

Exclusion Criteria:

- Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as
related to BAY63-2521 are not allowed to participate in the extension trial



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: Riociguat (Adempas, BAY63-2521)

Primary Outcome(s)

Number of Participants With Death [Time Frame: From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit)]

Number of Participants With Treatment-emergent Adverse Events (TEAE) [Time Frame: From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years]

Secondary Outcome(s)

Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry [Time Frame: From baseline to Termination visit, up to 10 years]

Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation [Time Frame: From baseline to Termination visit, up to 10 years]

Change From Baseline of Hemoglobin in Hematology and Coagulation [Time Frame: From baseline to Termination visit, up to 10 years]

Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry [Time Frame: From baseline to Termination visit, up to 10 years]

Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation [Time Frame: From baseline to Termination visit, up to 10 years]

Change From Baseline of Urate in Clinical Chemistry [Time Frame: From baseline to Termination visit, up to 10 years]

Secondary ID(s)

11349

2008-003539-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00910429