Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients
- Registration Number
- NCT01868685
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
- Patients deemed to be terminal wean patients.
- Patients who have progressive neuromuscular degenerative disorders.
- Patients who are comatose.
- Evidence of unstable medical status.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BYM338 BYM338 -
- Primary Outcome Measures
Name Time Method Change in thigh muscle thickness After 14 days
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events as a measure of safety and tolerability After 12 weeks Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients After 12 weeks