Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency

This study has been terminated.

( Decision to discontinue was due to the challenges of the trial design and the constraints on enrolling eligible and consenting patients. )

Study NCT00748579 Information provided by Cytokinetics

First Received on April 21, 2008. Last Updated on August 24, 2010 History of Changes

Results First Received: July 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Heart Failure
Intervention:	Drug: CK-1827452

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from September 2008 to July 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Mid Dose CK-1827452 (Cohort 1)	0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
High Dose CK-1827452 (Cohort 2)	≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452

Participant Flow: Overall Study

	Mid Dose CK-1827452 (Cohort 1)	High Dose CK-1827452 (Cohort 2)
STARTED	2	0
COMPLETED	2	0
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Mid Dose CK-1827452 (Cohort 1)	0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
High Dose CK-1827452 (Cohort 2)	≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452

Baseline Measures

	Mid Dose CK-1827452 (Cohort 1)	High Dose CK-1827452 (Cohort 2)	Total
Number of Participants [units: participants]	2	0	2
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	1	0	1
>=65 years	1	0	1
Age [units: years] Mean ± Standard Deviation	69 ± 13		69 ± 13
Gender [units: participants]
Female	2	0	2
Male	0	0	0
Region of Enrollment [units: participants]
United States	2	0	2

Outcome Measures

1. Primary:

Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption. [ Time Frame: 1 day ]

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2. Secondary:

Effects of CK-1827452 on Ventricular Performance, Myocardial Oxygen Consumption, Pressure-volume Relationships, Systolic Ejection Time and Invasively Measured Hemodynamics, Including Filling Pressures and Cardiac Output. [ Time Frame: 1 day ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor's intention was to publish the results of the trial in collaboration with the Investigators.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Inadequate enrollment led to early termination of study and insufficient number of patients for analysis.

Results Point of Contact:

Name/Title: Medical Director
Organization: Cytokinetics, Inc.
phone: (650) 624-3011

No publications provided

Responsible Party:	Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer, Cytokinetics, Inc.
ClinicalTrials.gov Identifier:	NCT00748579 History of Changes
Other Study ID Numbers:	CY 1124
Study First Received:	April 21, 2008
Results First Received:	July 30, 2010
Last Updated:	August 24, 2010
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada