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NCT04813926 · ClinicalTrials.gov registry record
A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH)
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 500
- Enrollment target
NCT04813926: Completed study, sponsored by Bayer.
NCT04813926 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 500 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04813926 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 500 participants
- Enrollment target
Study Summary
Pulmonary arterial hypertension (PAH) is a type of high blood pressure in the arteries that carry blood from the heart to the lungs. PAH occurs when the openings in the blood vessels of the lungs get smaller and smaller. These smaller openings can be caused by the following: * The walls of the arteries tightening * The walls of the arteries becoming stiff and narrow from an overgrowth of cells The increased pressure in the pulmonary arteries strains the right side of the heart and it begins to fail, causing difficulty breathing and other symptoms. As PAH progresses, symptoms get worse. There is no cure for PAH, but several medications like endothelin receptor antagonists (ERAs), prostacyclin analogues (PCAs) and riociguat, a soluable guanylate cyclase stimulator, are available to help slow the progression of changes in the pulmonary arteries and help reduce symptoms. Riociguat can be taken together with ERAs and PCAs. In this study, the researchers want to learn about how well riociguat works, how safe it is when patients take it in 1 of these ways: * alone * with ERA * with PCA * with ERA and PCA The dosage for each patient will be decided by their doctor. The researchers will review information collected from the patients who have decided with their doctor to start riociguat treatment for their PAH. The study will include about 500 patients in the United States who are at least 18 years old. All of the patients will have either just started taking riociguat or will have been taking it for less than 3 months No investigational products will be administered in this study. Patients will be treated with the Standard of Care (SOC) for PAH. The SOC is the currently appropriate treatment in accordance with scientific evidence and agreed upon in collaboration between medical experts for PAH. There will be no study-mandated visits or treatments. The patients will be in the study for up to 2 years. During this time, they will visit their doctor every 3 to 6 months as p
Interventions
- DRUG Riociguat (Adempas, BAY63-2521)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2021-07-16 |
| Est. Completion | 2025-02-03 |
What the finished NCT04813926 record still lists
NCT04813926 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Riociguat (Adempas, BAY63-2521) is the first listed.
NCT04813926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04813926 about?
NCT04813926 is a clinical study titled "A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH)". Pulmonary arterial hypertension (PAH) is a type of high blood pressure in the arteries that carry blood from the heart to the lungs. PAH occurs when the openings in the blood vessels of the lungs get smaller and smaller. These smaller openings can be caused by the following: * The walls of the arte...
What is the current status of trial NCT04813926?
This trial is currently completed. The enrollment target is 500 participants. The study started on 2021-07-16. Estimated completion is 2025-02-03.
What interventions are being tested in trial NCT04813926?
The interventions under investigation include: Riociguat (Adempas, BAY63-2521) (DRUG).
Who is sponsoring clinical trial NCT04813926?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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