No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
332 (estimated)
Sponsor
Kardigan, Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Danicamtiv is an investigational medication, which means it is still being studied and has not been approved. The purpose of this study is to learn how well danicamtiv works, how safe it is, how well people can take it when used in patients with genetic or familial dilated cardiomyopathy (DCM). There are currently no approved medicines made specifically to treat genetic or familial DCM.
Trial Locations
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State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Completed 24 weeks of blinded study treatment (corresponding to the Week 26 Visit in DAN-301) and planned assessments in Part 1 or Part 2 of the DAN-301 study.
2. If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months af…
Inclusion Criteria:
1. Completed 24 weeks of blinded study treatment (corresponding to the Week 26 Visit in DAN-301) and planned assessments in Part 1 or Part 2 of the DAN-301 study.
2. If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months after the last dose.
3. Is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to local and institutional guidelines before the first study-specific procedure.
Exclusion Criteria:
1. Acute coronary syndrome or hemodynamically significant epicardial coronary disease, or coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]) performed within 90 days of DAN-302 Screening Visit.
2. Recent (\<90 days) hospitalization for heart failure (HF) or use of IV diuretic.
3. Other recent (\<90 days) cardiovascular events (e.g., cerebrovascular accident).
4. Hospitalization for sepsis or other systemic infections within 30 days of Screening. A systemic infection includes suspected or confirmed infection associated with fever, hemodynamic instability, bacteremia, or organ dysfunction typically requires urgent evaluation and/or acute care.
5. Any malignancy requiring treatment after enrollment in DAN-301 that could limit patient's survival.
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