BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
This study is not yet open for participant recruitment.
Verified August 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01669174
First received: March 1, 2012
Last updated: August 30, 2012
Last verified: August 2012
Tracking Information | |
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First Received Date ICMJE | March 1, 2012 |
Last Updated Date | August 30, 2012 |
Start Date ICMJE | August 2012 |
Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Change in thigh muscle volume compare to placebo as measured by MRI [ Time Frame: after 6 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE |
Change in thigh muscle volume compare to placebo as measured by MRI [ Time Frame: 4, 8, 16 and 24 weeks ] [ Designated as safety issue: No ] |
Change History | Complete list of historical versions of study NCT01669174 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia |
Official Title ICMJE | A Randomized, Double Blind, Placebo Controlled, Multi-centre Study to Asses the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of a Single Dose of BYM338 in Chronic Obstructive Pulmonary Disease Patients With Cachexia |
Brief Summary | This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks. |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
Condition ICMJE | Chronic Obstructive Pulmonary Disease (COPD) |
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Not yet recruiting |
Estimated Enrollment ICMJE | 60 |
Completion Date | |
Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients. Other protocol-defined inclusion/exclusion criteria may apply |
Gender | Both |
Ages | 40 Years to 80 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | United States, Netherlands, United Kingdom |
Administrative Information | |
NCT Number ICMJE | NCT01669174 |
Other Study ID Numbers ICMJE | CBYM338X2204 |
Has Data Monitoring Committee | |
Responsible Party | Novartis ( Novartis Pharmaceuticals ) |
Study Sponsor ICMJE | Novartis Pharmaceuticals |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Novartis |
Verification Date | August 2012 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |