Trials / Completed
CompletedNCT03547583
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 789 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets | Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6. |
| DRUG | Placebo | Placebo and sham up-titration at weeks 2, 4, and 6 |
Timeline
- Start date
- 2018-06-15
- Primary completion
- 2019-10-15
- Completion
- 2019-11-04
- First posted
- 2018-06-06
- Last updated
- 2021-01-06
- Results posted
- 2020-12-03
Locations
177 sites across 21 countries: United States, Argentina, Austria, Belgium, Bulgaria, Canada, Colombia, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Poland, Portugal, Russia, Singapore, South Africa, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03547583. Inclusion in this directory is not an endorsement.