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NCT02007629 · ClinicalTrials.gov registry record · Phase 3
Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT02007629 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 61 participants.
The verdict
NCT02007629, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study Summary
BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects. Here dose of Riociguat will be adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on previous evidence and on the different modes of action an improvement of exercise capacity, heart function and quality of life may be expected if PDE5i treatment is transitioned to riociguat. Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months (Extended Drug Supply Phase - EDSP) under study conditions. Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named patient program. Study termination is also possible at any time.
Interventions
- DRUG Riociguat (Adempas, BAY63-2521)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2014-02-18 |
| Est. Completion | 2016-12-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02007629
The ClinicalTrials.gov registry entry for NCT02007629 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Riociguat (Adempas, BAY63-2521) is the first listed.
NCT02007629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02007629 about?
NCT02007629 is a clinical study titled "Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor". BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function with...
What is the current status of trial NCT02007629?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2014-02-18. Estimated completion is 2016-12-29.
What interventions are being tested in trial NCT02007629?
The interventions under investigation include: Riociguat (Adempas, BAY63-2521) (DRUG).
Who is sponsoring clinical trial NCT02007629?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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