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CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for CK-3773274

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04848506
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Cytokinetics

Brief Summary:
The purpose of this study is to collect long-term safety and tolerability data for CK-3773274

Condition or disease Intervention/treatment Phase
Obstructive Hypertrophic Cardiomyopathy Drug: CK-3773274 (5 - 15 mg) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of CK-3773274 for Patients With Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract Obstruction
Actual Study Start Date : May 6, 2021
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026


Arm Intervention/treatment
Experimental: CK-3773274 up to 15 mg
Patients in this arm take daily dose of CK-3773274. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.
Drug: CK-3773274 (5 - 15 mg)
CK-3773274 tablets administered orally




Primary Outcome Measures :
  1. Incidence of adverse events observed during dosing of CK-3773274 in patients with oHCM [ Time Frame: To End of study, up to 5 years ]
    Patient incidence of reported Adverse Events (AEs)


Secondary Outcome Measures :
  1. Incidence of serious adverse events observed during dosing of CK-3773274 in patients with oHCM [ Time Frame: To End of study, up to 5 years ]
    Patient incidence of reported Serious Adverse Events (SAEs)

  2. Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with oHCM [ Time Frame: To End of study, up to 5 years ]
    Patient incidence of reported LVEF <50%

  3. Long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT G) [ Time Frame: Baseline through the end of participation at 12-week intervals ]
    Peak LVOT-G at rest



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of a Cytokinetics trial investigating CK-3773274
  • LVEF ≥55% at the Screening Visit

Exclusion Criteria:

  • Has taken any investigational study drug other than CK-3773274 within 30 days prior to screening
  • Since completion of a previous trial of CK-3773274 has:

    • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days
    • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
  • Has current obstructive coronary artery disease (>70% stenosis documented in one or more arteries)
  • Has moderate or severe aortic valve stenosis
  • Had a confirmed LVEF <40% with an associated dose interruption during CY 6021
  • Has been treated with drugs that have negative inotropic activity (except for beta- blockers, calcium channel blockers, or disopyramide) as monotherapy or in combination within 30 days prior to screening. Patients receiving treatment with disopyramide require approval from the medical monitor prior to enrollment.
  • History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening
  • History of appropriate ICD shock within 30 days prior to screening
  • Has received treatment with mavacamten within 3 months prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04848506


Contacts
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Contact: Cytokinetics, MD 650-624-2929 medicalaffairs@cytokinetics.com

Locations
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United States, California
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Michigan Medicine - University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Trina Lowther, MD    503-494-3253    lowthert@ohsu.edu   
Sponsors and Collaborators
Cytokinetics
Investigators
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Study Director: Cytokinetics, MD Cytokinetics
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Responsible Party: Cytokinetics
ClinicalTrials.gov Identifier: NCT04848506    
Other Study ID Numbers: CY 6022
2020-003571-17 ( EudraCT Number )
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cytokinetics:
Obstructive Hypertrophic Cardiomyopathy
oHCM
CK-3773274
CK-274
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases