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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516349-38-00 | EU Trial (CTIS) Number |
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This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CK-4021586 - Cohort 1 | Experimental | Participants may receive 150 mg or 300 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
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| Placebo - Cohort 1 | Placebo Comparator | Participants will receive placebo daily for up to 12 weeks. |
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| CK-4021586 - Cohort 2 | Experimental | Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
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| Placebo - Cohort 2 | Placebo Comparator | Participants will receive placebo daily for up to 12 weeks. |
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| CK-4021586 - Cohort 3 | Experimental | Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg) | Drug | CK-4021586 administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early drug discontinuation | Incidence of early drug discontinuation observed during dosing of CK 4021586 in patients with HFpEF | 12 weeks |
| Incidence of LVEF < 40% | Incidence of left-ventricular ejection fraction (LVEF) < 40% observed during dosing of CK-4021586 in patients with HFpEF | 12 weeks |
| Incidence of AEs | Incidence of adverse events observed during dosing of CK-4021586 in patients with HFpEF | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NT-proBNP | Change from baseline values in NT-proBNP to Week 6 and Week 12 | Baseline to Week 6 and Week 12 |
| Plasma concentrations of CK-4021586 | Observed 2-hour post dose plasma concentration (C2hr) and minimum plasma concentration (Cmin) for CK-4021586 over the dosing interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cytokinetics MD | Contact | 650-624-2929 | medicalaffairs@cytokinetics.com |
| Name | Affiliation | Role |
|---|---|---|
| Cytokinetics MD | Cytokinetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Shore Research Institute, LLC | Recruiting | Fairhope | Alabama | 36532 | United States | |
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| Placebo - Cohort 3 |
| Placebo Comparator |
Participants will receive placebo daily for up to 12 weeks. |
|
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| Placebo to match CK-4021586 | Drug | Placebo administered orally |
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| 12 weeks |
| Concentration-response relationship of CK-4021586 on NT-proBNP change | Slope of the relationship of plasma concentration of CK-4021586 to the change from baseline in the NT-proBNP | Baseline to Week 12 |
| Concentration-response relationship of CK-4021586 to LVEF change | Slope of the relationship of plasma concentration of CK-4021586 to the change from baseline in the LVEF | Baseline to Week 12 |
| Change in LVEF | Change from baseline in LVEF at Week 6 and Week 12 | Baseline to Week 6 and Week 12 |
| University of Arizona Sarver Heart Center |
| Recruiting |
| Tucson |
| Arizona |
| 85724 |
| United States |
| John L. McClellan Memorial Veterans Hospital | Recruiting | Little Rock | Arkansas | 72205 | United States |
| BioSolutions Clinical Research Center | Recruiting | Imperial | California | 92251 | United States |
| Profound Research LLC | Recruiting | Pasadena | California | 91105 | United States |
| University of California, San Francisco - Heart and Vascular Center | Recruiting | San Francisco | California | 94143 | United States |
| FOMAT - Comprehensive Cardiovascular Care | Recruiting | Santa Maria | California | 93454 | United States |
| Blue Coast Research Center, LLC | Recruiting | Vista | California | 92081 | United States |
| New Generation of Medical Research | Recruiting | Hialeah | Florida | 33016 | United States |
| Cleveland Clinic Florida | Recruiting | Weston | Florida | 33331 | United States |
| Methodist Medical Center of Illinois | Recruiting | Peoria | Illinois | 61636 | United States |
| Louisiana Heart Center | Recruiting | Slidell | Louisiana | 70458 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02214 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Washington University Center for Advanced Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Morristown Medical Center | Recruiting | Morristown | New Jersey | 07960 | United States |
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| Mount Sinai West | Recruiting | New York | New York | 10019 | United States |
| The Lindner Center for Research & Education at The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
| University of Texas Southwestern Medical Center, Dallas | Recruiting | Dallas | Texas | 75390 | United States |
| Center for Advanced Heart Failure | Recruiting | Houston | Texas | 77030 | United States |
| DelRicht Research | Withdrawn | Vienna | Virginia | 22182 | United States |
| Swedish Heart & Vascular Institute, Advanced Cardiac Support Program | Recruiting | Seattle | Washington | 98122 | United States |
| Froedtert Hospital - Center for Advanced Care | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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