Efficacy & Safety of Resatorvid in Adults With Severe Sepsis
A Pivotal, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety of TAK-242 in Adults With Severe Sepsis
4 other identifiers
interventional
277
16 countries
142
Brief Summary
The purpose of this study is to determine the optimal dose of Resatorvid for reducing 28-day all-cause mortality in subjects with severe sepsis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 sepsis
Started Sep 2005
Shorter than P25 for phase_3 sepsis
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2005
CompletedStudy Start
First participant enrolled
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFebruary 2, 2012
January 1, 2012
1.4 years
August 31, 2005
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
28-day All-cause Mortality.
Day 28
Secondary Outcomes (6)
Change from Baseline in Organ Failure Assessment
Day 28
Mean Systemic Inflammatory Response
Day 28
Mean Vasopressor-free days
Day 28
Mean Ventilator-free days
Day 28
Mean Intensive Care Unit free days
Day 28
- +1 more secondary outcomes
Study Arms (3)
Resatorvid 1.2 mg/kg/day
EXPERIMENTALResatorvid 2.4 mg/kg/day
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.05 mg/kg/h (1.2 mg/kg/day), injection, subcutaneously over 96 hours.
Resatorvid placebo-matching injection, subcutaneously for thirty minutes; then resatorvid placebo-matching injection, subcutaneously over 96 hours.
Eligibility Criteria
You may qualify if:
- Has clinical evidence of infection defined as the presence of a known or probable source of infection requiring the initiation of parenteral antimicrobial therapy.
- Must meet at least 3 of the following 4 criteria for SIRS:
- A core temperature greater than 38°C or less than 36°C.
- A heart rate greater than 90 beats per minute.
- A respiratory rate greater than 20 breaths/min or partial pressure of carbon dioxide in arterial blood less than 32 mm Hg or mechanical ventilation for an acute process.
- A total white blood cell absolute count greater than 12,000 cells/mm3 or less than 4,000 cells/mm3, or a white blood cell differential count that showed greater than 10% immature (band) forms.
- Must have sepsis with shock and/or respiratory failure.
You may not qualify if:
- If female, the subject is pregnant, nursing and the milk is intended to be ingested by the infant, or the participant plans to become pregnant, or nurse and the milk is intended to be ingested by the infant.
- Is receiving immunosuppressive therapy such as cyclosporine, azathioprine, or cancer-related chemotherapy.
- Has a granulocyte count of less than 1000/mm3 except if the decreased count was believed to be due to sepsis.
- Has documented or suspected acute myocardial infarction within the last 6 weeks prior to Pretreatment Period.
- Has a documented history of moderate to severe chronic heart failure as defined by New York Heart Association Functional Classification III or IV.
- Is known to be positive for human immunodeficiency virus with known CD4 count less than or equal to 50/mm3 or had known end-stage processes.
- Has a known history of glucose-6-phosphate dehydrogenase deficiency.
- Has a methemoglobin level greater than 5% at Pretreatment Period or had a known history of methemoglobinemia.
- Is moribund and death was considered imminent.
- Is classified as "Do Not Resuscitate", or "Do Not Treat", or the participant's family has not committed to aggressive management of the participant's condition.
- Is not expected to survive for 28 days and was not likely be given life support due to a pre-existing, uncorrectable medical condition.
- Has a known esophageal varices, chronic jaundice, cirrhosis, or chronic ascites.
- Is in a chronic vegetative state or has a similar long-term neurological condition.
- Has known portal hypertension or Child-Pugh hepatic impairment class C.
- Has acute third degree burns involving more than 30% of body surface within 120 hours prior to Pretreatment Period.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (144)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Escondido, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Poway, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Atlantis, Florida, United States
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Bay Pines, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Louisville, Kentucky, United States
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Shreveport, Louisiana, United States
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Portland, Maine, United States
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Baltimore, Maryland, United States
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Springfield, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Englewood, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Greensboro, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Greenville, South Carolina, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Bellevue, Washington, United States
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Adelaide, Australia
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Fremantle, Australia
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Heidelberg, Australia
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Linz, Austria
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Vienna, Austria
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Aalst, Belgium
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Antwerp, Belgium
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Brussels, Belgium
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Genk, Belgium
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Ghent, Belgium
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Liège, Belgium
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Ottignies, Belgium
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Yvoir, Belgium
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Brno, Czechia
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Havlíčkův Brod, Czechia
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Hradec Králové, Czechia
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Opava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Helsinki, Finland
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Joensuu, Finland
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Kokkola, Finland
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Kuopio, Finland
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Lappeenranta, Finland
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Oulu, Finland
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Seinäjoki, Finland
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Tampere, Finland
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Turku, Finland
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Berlin, Germany
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Dresden, Germany
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Erfurt, Germany
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Jena, Germany
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Krefeld, Germany
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Ludwigshafen, Germany
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Mannheim, Germany
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München, Germany
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Wuppertal, Germany
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Afula, Israel
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Ashkelon, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Ẕerifin, Israel
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Lecco, Italy
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Monza, Italy
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Pavia, Italy
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Chiba, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Numakunai, Japan
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Osaka, Japan
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Shizuoka, Japan
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Tokyo, Japan
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Yamaguchi, Japan
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's-Hertogenbosch, Netherlands
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Apeldoorn, Netherlands
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Groningen, Netherlands
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Leeuwarden, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Tilburg, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Hastings, New Zealand
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Tauranga, New Zealand
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San Juan, Puerto Rico
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Barcelona, Spain
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Getafe, Spain
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Madrid, Spain
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Valladolid, Spain
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Vitoria-Gasteiz, Spain
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Gävle, Sweden
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Gothenburg, Sweden
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Karlstad, Sweden
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Kristianstad, Sweden
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Linköping, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Brighton, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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Livingston, United Kingdom
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London, United Kingdom
Related Publications (1)
Rice TW, Wheeler AP, Bernard GR, Vincent JL, Angus DC, Aikawa N, Demeyer I, Sainati S, Amlot N, Cao C, Ii M, Matsuda H, Mouri K, Cohen J. A randomized, double-blind, placebo-controlled trial of TAK-242 for the treatment of severe sepsis. Crit Care Med. 2010 Aug;38(8):1685-94. doi: 10.1097/CCM.0b013e3181e7c5c9.
PMID: 20562702RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP Clinical Science
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
September 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
February 2, 2012
Record last verified: 2012-01