BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT00863681
• Date of registration: 13/03/2009
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension PATENT-2
• Scientific title: Long-term Extension, Multicentre, Multi-national 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 Symptomatic Pulmonary Arterial Hypertension (PAH)
• Date of first enrolment: March 12, 2009
• Target sample size: 396
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00863681
• 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, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1

Exclusion Criteria:

- Patients who have an ongoing serious adverse event from PATENT 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

Hypertension, Pulmonary

Intervention(s)

Drug: Riociguat (BAY63-2521)

Primary Outcome(s)

Number of Participant With Death [Time Frame: From baseline to end of safety follow-up visit, up to 10 years and 6 months (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 in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.]

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 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]

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

Secondary ID(s)

2008-003610-94

12935

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/NCT00863681