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NCT03547583 · ClinicalTrials.gov registry record · Phase 2
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
A Phase 2 study of Chronic Heart Failure With Preserved Ejection Fraction, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 789
- Enrollment target
- 20
- Study locations
NCT03547583 is a Phase 2 study of Chronic Heart Failure With Preserved Ejection Fraction that has completed, run by Bayer. The registered enrollment target is 789 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT03547583, a Phase 2 study of Chronic Heart Failure With Preserved Ejection Fraction, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 789 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
Study Locations (20)
Florida
- Cardiology Associates Of South Florida PA - Boynton Beach
- Cardiovascular and Vein Center of Florida - Bradenton
- Cardiology Associates Research Company - Daytona Beach
- LifeSpring Research Foundation, LLC - Miami
- Southwest Florida Research - Naples
- East Coast Institute for Research, LLC - Saint Augustine
- Cardiology Partners - Wellington
California
- WestSide Medical - Beverly Hills
- Capitol Interventional Cardiology - Carmichael
- Interventional Cardiology Medical Group - West Hills
Illinois
- Fox Valley Clinical Research Center, LLC - Aurora
- Advocate Condell Medical Center - Libertyville
Colorado
- Penrose-St. Francis Health Services - Colorado Springs
Connecticut
- Cardiology Associates of Fairfield County, PC - Trumbull
Indiana
- Reid Health - Richmond
Kentucky
- Research Integrity, LLC - Owensboro
Louisiana
- Heart Clinic of Hammond - Hammond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 789 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2019-11-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03547583
The ClinicalTrials.gov registry entry for NCT03547583 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 789 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 1 condition, with Chronic Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03547583 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT03547583 about?
NCT03547583 is a clinical study titled "Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF". The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.
What is the current status of trial NCT03547583?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 789 participants. The study started on 2018-06-15. Estimated completion is 2019-11-04.
What conditions does trial NCT03547583 study?
This clinical trial studies the following conditions: Chronic Heart Failure With Preserved Ejection Fraction.
What interventions are being tested in trial NCT03547583?
The interventions under investigation include: Placebo (DRUG), Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets (DRUG).
Who is sponsoring clinical trial NCT03547583?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03547583 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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