Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/5/2014 |
| Start Date: | February 2014 |
| End Date: | November 2014 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
An Exploratory, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of BYM338 on Muscle in Patients Requiring Prolonged Mechanical Ventilation
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.
Group III failure to wean patients, as compared to placebo controls.
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.
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