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

Phase 3

Completed

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

• Registration Number: NCT00910429
• Lead Sponsor: Bayer

Brief Summary

Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

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 First Submitted: 2009-05-27
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Study Start: 2009-07-01
• 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: 237

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Death	From baseline to end of safety follow-up visit, up to 10 years (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.
Number of Participants With Treatment-emergent Adverse Events (TEAE)	From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years	Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry	From baseline to Termination visit, up to 10 years	Frequency 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. 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	Frequency 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. 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 Hematology and Coagulation	From baseline to Termination visit, up to 10 years	Frequency 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. 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.
Change From Baseline of Hemoglobin in Hematology and Coagulation	From baseline to Termination visit, up to 10 years	Hemoglobin is standard Hematology and coagulation parameter. 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	Frequency 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. 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.
Change From Baseline of Urate in Clinical Chemistry	From baseline to Termination visit, up to 10 years	Urate is standard clinical chemistry parameter. 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 (2)

Rabin Medical Center - Beilinson Campus; 🇮🇱 Petach Tikva, Israel

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