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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
ClinicalTrials.gov Identifier:
NCT00633477
First received: March 4, 2008
Last updated: January 10, 2013
Last verified: January 2013
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

2.  Primary:   All-cause Mortality   [ Time Frame: Day 28 ]

3.  Secondary:   ICU Free Days   [ Time Frame: Day 28 ]

4.  Secondary:   Vasopressor Free Days.   [ Time Frame: Day 28 ]

5.  Secondary:   Ventilator Free Days.   [ Time Frame: Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


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
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