Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

January 6, 2015 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: BYM338
Drug: BYM338
BYM338

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in thigh muscle thickness
Time Frame: After 14 days
After 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events as a measure of safety and tolerability
Time Frame: After 12 weeks
After 12 weeks
Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients
Time Frame: After 12 weeks
After 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 7, 2015

Last Update Submitted That Met QC Criteria

January 6, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CBYM338X2207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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