Efficacy and Safety of Resatorvid in Patients With Sepsis-induced Cardiovascular and Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT00633477|
Recruitment Status : Terminated (Business Decision; No Safety Or Efficacy Concerns.)
First Posted : March 12, 2008
Results First Posted : January 9, 2013
Last Update Posted : January 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Drug: Resatorvid Drug: Placebo||Phase 3|
Sepsis is a major cause of in-hospital death, with a higher mortality rate than events such as stroke and acute myocardial infarction, each with less than a 20% risk of death in the first 30 days. Sepsis is a clinical condition caused by the innate inflammatory host response to systemic infection that can result in organ failure and potentially death. Under certain circumstances, many components of the innate immune response that are normally involved with host defense can cause cell and tissue damage and subsequently multiple organ failure, the clinical hallmark of severe sepsis.
The host response to infection is characterized by the synthesis and release of proinflammatory cytokines. Cytokines are released by signals transmitted from the surface of inflammatory cells, after binding of pathogen-associated molecules to cell surface pattern recognition receptors known as toll-like receptors.
TAK-242 (resatorvid) is a toll-like receptor 4 inhibitor under clinical development for the treatment of patients with severe sepsis. Study participation is anticipated to be about 28 days, with an additional 9 month follow-up period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of TAK-242 Versus Placebo in Subjects With Sepsis-Induced Cardiovascular and Respiratory Failure|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
|Experimental: Resatorvid 2.4 mg/kg/day||
Resatorvid 1.2 mg/kg emulsion, injection for 30 minutes and resatorvid 2.4 mg/kg per-day emulsion, injection, continuous infusion for 96 hours.
Other Name: TAK-242
|Placebo Comparator: Placebo||
Resatorvid placebo-matching emulsion, injection for 30 minutes and resatorvid placebo-matching emulsion, injection, continuous infusion for 96 hours.
- All-cause Mortality [ Time Frame: Day 28 ]Mortality regardless of cause at Day 28
- ICU Free Days [ Time Frame: Day 28 ]Number days participant was not in ICU
- Vasopressor Free Days. [ Time Frame: Day 28 ]Number days participant did not need vasopressors.
- Ventilator Free Days. [ Time Frame: Day 28 ]Number days participant was not on Ventilattor support.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633477
|Study Director:||VP Clinical Science||Takeda|