Study of Muscle Effects of BYM338 in mechanically Ventilated Patients

Phase 1

• Conditions: Group III failure to wean patients; MedDRA version: 16.1Level: PTClassification code 10067221Term: Mechanical ventilationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-002201-66-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Patients deemed to be treminal wean patients.
- Patients who have progressive neuromuscular degenerative disorders.
- Patients who are comatose
- Evidence of unstable medical status.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified