Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics o… (NCT04219826) | Clinical Trial Compass
CompletedPhase 2
Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
United States96 participantsStarted 2020-01-10
Plain-language summary
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria
* Males and females between 18 and 85 years of age at screening.
* Body weight is ≥45 kg at screening.
* Diagnosed with HCM per the following criteria:
* Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease.
* Has minimal wall thickness ≥15 mm (minimal wall thickness ≥13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation).
* Adequate acoustic windows for echocardiography.
* For Cohorts 1, 2 and 3 has LVOT-G during screening as follows:
* Resting gradient ≥50 mmHg OR
* Resting gradient ≥30 mmHg and \<50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
* For Cohort 4 has resting and post-Valsalva LVOT-G \< 30 mmHg at the time of screening
* For Cohort 4 has elevated NT-proBNP \> 300 pg/mL at the time of screening
* LVEF ≥60% at screening.
* New York Heart Association (NYHA) Class II or III at screening.
* Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for \>4 weeks prior to randomization and anticipate remaining on the same medication regimen during the study.
* For Cohort 3: Patients must be taking disopyramide. Patients should have been on stable disopyramide doses for \>4 weeks prior to screening and anticipate remaining on the same medication regimen during the study.
Exclusion Criteria
* Aortic stenosis or fixed subaortic obstruction.
* Known infiltrative or storage disorder causing cardiac hypertroph…
What they're measuring
1
Incidence of Adverse Events (AEs)
Timeframe: 14 weeks
2
Incidence of Left Ventricular Ejection Fraction (LVEF) < 50%