Status:
WITHDRAWN
Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Mechanical Ventilation
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.
Eligibility Criteria
Inclusion
- Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for \>24 hours.
- Expected to survive at least 14 days.
- Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status).
Exclusion
- Patients deemed to be terminal wean patients.
- Patients who have progressive neuromuscular degenerative disorders.
- Patients who are comatose.
- Evidence of unstable medical status.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01868685
Start Date
April 1 2014
End Date
January 1 2015
Last Update
January 7 2015
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