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NCT02891850 · ClinicalTrials.gov registry record · Phase 4
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
A Phase 4 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 4
- Development phase
- 225
- Enrollment target
NCT02891850: Completed Phase 4 study, sponsored by Bayer.
NCT02891850 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 225 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02891850, a Phase 4 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 225 participants
- Enrollment target
Study Summary
To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients
Primary Outcome
The treatment is assessed as efficient (participants with satisfactory clinical response) in case at least 2 out of the following 3 criteria were fulfilled * 6 Minute Walking Distance increase by ≥ 10% or ≥ 30 m from baseline to Week 24 * World Health Organization Functional Class (WHO FC) I or II at Week 24 * N-terminal pro-brain natriuretic peptide (NT-proBNP) reduction ≥ 30% from baseline to Week 24 (NT-proBNP ratio Week 24/baseline ≤ 0.7) and in absence of the defined criteria of clinical w
Interventions
- DRUG Sildenafil
- DRUG Tadalafil
- DRUG Riociguat (Adempas, BAY63-2521)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2017-01-11 |
| Est. Completion | 2020-03-03 |
| Phase | Phase 4 |
What the finished NCT02891850 record still lists
NCT02891850 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Sildenafil is the first listed.
NCT02891850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02891850 about?
NCT02891850 is a clinical study titled "Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy". To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients
What is the current status of trial NCT02891850?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 225 participants. The study started on 2017-01-11. Estimated completion is 2020-03-03.
What interventions are being tested in trial NCT02891850?
The interventions under investigation include: Sildenafil (DRUG), Tadalafil (DRUG), Riociguat (Adempas, BAY63-2521) (DRUG).
Who is sponsoring clinical trial NCT02891850?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02891850's enrollment target sits among peer trials
225 379th of 2000 higher than 1,622 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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