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

Phase 3

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Riociguat (BAY63-2521)

• Registration Number: NCT00863681
• Lead Sponsor: Bayer

Brief Summary

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-03-12
• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Primary Completion: 2019-08-19
• Study Completion: 2019-08-19
• Results First Submitted: 2020-08-17
• Results First Submitted QC: 2020-09-29
• Results First Posted: 2020-10-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Riociguat (BAY63-2521)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAE)	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.	Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
Number of Participant With Death	From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit)	Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation	From baseline to termination visit, up to 10 years	Percentage of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after start of treatment.; A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation	From baseline to termination visit, up to 10 years	Percentage of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after start of treatment.; A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry	From baseline to termination visit, up to 10 years	Percentage of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after start of treatment.; A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry	From baseline to termination visit, up to 10 years	Percentage of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after start of treatment.; A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.

Trial Locations

Locations (3)

Centro Hospitalar de Lisboa Norte - Hospital Santa Maria; 🇵🇹 Lisboa, Portugal

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"; 🇲🇽 Guadalajara, Jalisco, Mexico

Pulmocritic; 🇲🇽 Guadalajara, Jalisco, Mexico