Phase 3
N=396
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension
Hypertension, Pulmonary
Bottom Line
View on ClinicalTrials.gov: NCT00863681 ↗Enrolled (actual)
396
Serious AEs
69.7%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAE) — 229; 108; 56; 138 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Riociguat (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) |
229; 108; 56; 138; 74; 30 | — |
| PRIMARY Number of Participant With Death |
48; 30; 7 | — |
| SECONDARY Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation |
68.1; 80.0; 79.2; 1.0; 1.1; 2.0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation |
12.8; 13.5; 8.5; 31.0; 22.8; 25.0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry |
13.4; 12.0; 8.7; 0.5; 1.0; 0.0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry |
0.0; 0.0; 0.0; 4.1; 4.0; 0.0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00863681). 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.