Phase 3
Completed N=237
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
Source: ClinicalTrials.gov NCT00910429 ↗Enrolled (actual)
237
Serious AEs
64.1%
Results posted
Oct 2020
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAE) — 153; 82; 77; 44 Participants
◆ Published Evidence
Highly cited
1,389citations · ~107 / year
Riociguat for the treatment of chronic thromboembolic pulmonary hypertension.
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.
Linked Publications (4)
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Riociguat for the treatment of chronic thromboembolic pulmonary hypertension.
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Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial.
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Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
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Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAE) |
153; 82; 77; 44; 96; 56 | — |
| PRIMARY Number of Participants With Death |
22; 13 | — |
| SECONDARY Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation |
97.1; 90.5; 1.4; 0.0; 18.4; 16.4 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation |
2.9; 2.7; 21.1; 29.7; 9.3; 17.6 | — |
| SECONDARY Change From Baseline of Hemoglobin in Hematology and Coagulation |
14.49; 14.36; 1.04; -1.37 | — |
| SECONDARY Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry |
11.5; 13.7; 0.0; 0.0; 22.0; 19.4 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry |
2.0; 0.0; 2.1; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline of Urate in Clinical Chemistry |
6.767; 6.999; 0.310; -1.290 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00910429) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.