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| Sponsored by: |
Cytokinetics |
|---|---|
| Information provided by: | Cytokinetics |
| ClinicalTrials.gov Identifier: | NCT00748579 |
Purpose
The purpose for this study (CY 1124) is to evaluate the effects of CK-1827452, a cardiac myosin activator, on myocardial systolic performance, myocardial oxygen consumption, and myocardial efficiency in patients with heart failure and to confirm that the unique preclinical pharmacological profile of CK- 1827452 is substantially the same in patients with heart failure.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: CK-1827452 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | A Phase II Open-Label Study to Investigate the Effects of CK-1827452 Injection on Ventricular Performance, Myocardial Oxygen Consumption, and Myocardial Efficiency in Patients With Heart Failure and Left Ventricular Systolic Dysfunction |
| Estimated Enrollment: | 18 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cohort 1: Experimental
0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452
|
Drug: CK-1827452
I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr
|
|
Cohort 2: Experimental
≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452
|
Drug: CK-1827452
I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient is considered to be in suitable health in the opinion of the investigator, as determined by:
Exclusion Criteria:
Contacts and Locations| Contact: Michael Felker, MD | felke001@mc.duke.edu |
| United States, Maryland | |
| Johns Hopkins Medical Institutions | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| United States, Utah | |
| UUHSC / Division of Cardiology | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Canada, Ontario | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 1X5 | |
More Information
| Responsible Party: | Cytokinetics, Inc. ( Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer ) |
| Study ID Numbers: | CY 1124 |
| Study First Received: | April 21, 2008 |
| Last Updated: | June 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00748579 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Heart Failure Heart Diseases |
|
Heart Failure Heart Diseases Cardiovascular Diseases |