Efficacy and Safety of Resatorvid in Patients With Sepsis-induced Cardiovascular and Respiratory Failure

This study has been terminated.

(Business Decision; No Safety Or Efficacy Concerns.)

Sponsor:

Information provided by (Responsible Party):

Takeda Global Research & Development Center, Inc.

ClinicalTrials.gov Identifier:

NCT00633477

First received: March 4, 2008

Last updated: January 10, 2013

Last verified: January 2013

History of Changes

Results First Received: December 5, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Sepsis
Interventions:	Drug: Resatorvid Drug: Placebo

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
Participants took part in the sudy at 11 centers in Japan and 1 center in the United States from 26 February 2008 to 20 February 2009 (day the decision was taken to terminate the study) .

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who met 3 of the 4 systemic inflammatory response syndrome (SIRS) criteria and receiving parentaeral antimicrobial therapy for bacterial or fungal infection prior to enrollment and met the key organ failure criteria within 36 hours of planned study drug administration were randomized to receive resatorvid or placebo.

Reporting Groups

	Description
Resatorvid	Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
Placebo	Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.

Participant Flow: Overall Study

	Resatorvid	Placebo
STARTED	7 ^[1]	11
Randomized But Not Treated	1	0
Prematurely Discontinued Study Drug	1	0
Completed Study Through Day 28	4	8
COMPLETED	5 ^[2]	11 ^[2]
NOT COMPLETED	2	0
Death	1	0
Randomized but not treated	1	0

[1]	Seven subjects were randomized, however, one was not treated.
[2]	Include all subjects who could be evaluated for 28-d survival.

Baseline Characteristics

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Reporting Groups

	Description
Resatorvid 2.4 mg/kg/Day	Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours
Placebo	Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
Total	Total of all reporting groups

Baseline Measures

	Resatorvid 2.4 mg/kg/Day	Placebo	Total
Number of Participants [units: participants]	6	11	17
Age [units: years] Mean ± Standard Deviation	76.7 ± 5.28	77.8 ± 13.56	77.4 ± 11.14
Age, Customized [units: Participants]
18 - <45	0	0	0
45 - <60	0	1	1
60 - <75	2	3	5
≥75	4	7	11
Gender [units: participants]
Female	0	4	4
Male	6	7	13
Race [units: Participants]
American Indian or Alaska Native	0	0	0
Asian	6	10	16
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	0	1	1
More than one race	0	0	0
Ethnicity [units: Participants]
Hispanic or Latino	0	0	0
Not Hispanic or Latino	0	1	1
Unknown or Not Reported	6	10	16
Weight [units: kg] Mean ± Standard Deviation	54.27 ± 12.9	58.24 ± 17.1	56.84 ± 15.4
Height [units: cm] Mean ± Standard Deviation	158.3 ± 6.0	160.7 ± 7.4	159.9 ± 6.9
Body Mass Index [units: kg/m2] Mean ± Standard Deviation	21.46 ± 3.97	22.59 ± 6.12	22.19 ± 5.36
Smoking Classification [units: Participant]
Never smoked	2	4	6
Current smoker	0	3	3
Ex-smoker	3	4	7
Smoking history not available	1	0	1

Outcome Measures

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1. Primary:

All-cause Mortality [ Time Frame: Day 28 ]

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2. Primary:

All-cause Mortality [ Time Frame: Day 28 ]

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3. Secondary:

ICU Free Days [ Time Frame: Day 28 ]

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4. Secondary:

Vasopressor Free Days. [ Time Frame: Day 28 ]

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5. Secondary:

Ventilator Free Days. [ Time Frame: Day 28 ]

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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: No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.

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
No text entered.

Results Point of Contact:

Name/Title: Takeda Study Registration Call Center
Organization: Takeda
phone: 800-778-2860
e-mail: medicalinformation@tpna.com

No publications provided

Responsible Party:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00633477 History of Changes
Other Study ID Numbers:	TAK-242_301, 2007-005687-27, U1111-1127-6016
Study First Received:	March 4, 2008
Results First Received:	December 5, 2012
Last Updated:	January 10, 2013
Health Authority:	United States: Food and Drug Administration Japan: Ministry of Health, Labor and Welfare

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