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BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01669174
First received: March 1, 2012
Last updated: April 27, 2016
Last verified: April 2016
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
Interventions: Drug: Placebo
Drug: BYM338

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BYM338 30 mg/kg
Placebo Placebo to BYM338 30mg/kg

Participant Flow:   Overall Study
    BYM338     Placebo  
STARTED     33     34  
COMPLETED     27     28  
NOT COMPLETED     6     6  
Subject withdrew consent                 2                 2  
Lost to Follow-up                 1                 0  
Adverse Event                 2                 2  
Administrative problems                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
BYM338 30 mg/kg
Placebo Placebo to BYM338 30mg/kg
Total Total of all reporting groups

Baseline Measures
    BYM338     Placebo     Total  
Number of Participants  
[units: participants]
  33     34     67  
Age  
[units: Years]
Mean (Standard Deviation)
  64.5  (5.93)     63.1  (7.51)     63.7  (6.76)  
Gender  
[units: Participants]
     
Female     16     18     34  
Male     17     16     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24   [ Time Frame: Baseline, Weeks 4, 8, 16, 24 ]

2.  Secondary:   Change in 6 Minute Walk Distance Compared to Placebo   [ Time Frame: Baseline, Weeks 4, 8, 16, 24 ]

3.  Secondary:   Maximum Observed Serum Concentration (Cmax)   [ Time Frame: 0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose ]

4.  Secondary:   Time to Reach the Maximum Concentration After Drug Administration (Tmax)   [ Time Frame: 24 weeks ]

5.  Secondary:   AUC0-56 and AUClast   [ Time Frame: 0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01669174     History of Changes
Other Study ID Numbers: CBYM338X2204
2011-000461-12
Study First Received: March 1, 2012
Results First Received: December 1, 2015
Last Updated: April 27, 2016
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: Medicines Evaluation Board (MEB)