Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Mechanical Ventilation

Treatments: Drug: BYM338; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01868685

CBYM338X2207

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BYM338

Experimental group

Treatment:

Drug: BYM338