AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorCytokinetics
About this trial
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Eligibility criteria
Qualifiers
Males and females ≥ 40 years and ≤ 85 years of age at screening.
Diagnosed with HF with NYHA functional class II or III.
Screening echocardiography with LVEF ≥ 60%.
Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with comorbid atrial fibrillation or flutter.
Disqualifiers
History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.
Other protocol-defined Inclusion/Exclusion criteria apply.
Trial design
Treatments tested in this trial
- CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
- Placebo to match CK-4021586
Treatment groups
60 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov