Phase 3
N=237
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00910429 ↗Enrolled (actual)
237
Serious AEs
64.1%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAE) — 153; 82; 77; 44 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Riociguat (Adempas, BAY63-2521) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Aug 2019
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 | — |
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.
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). 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.