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Tesamorelin in COPD with Muscle Wasting
NCT01388920Phase 2
Key facts
- Status
- Terminated
- Start
- Sep 2011
- Primary completion
- Dec 2011
- Sponsor
- Theratechnologies Inc.
- Modality
- Peptides
- Drugs
- tesamorelin
- Conditions
- muscle atrophy
01
Overview
Phase 2, randomised, double-blind trial of tesamorelin in muscle atrophy (3 arms), sponsored by Theratechnologies Inc. Primary endpoint: Change From Baseline in Lean Body Mass at 6 months. Started Sep 2011; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Tesamorelin 2 mg
Tesamorelin 2 mg/day
Tesamorelin 3 mg
Tesamorelin 3 mg/day
Placebo
Placebo
03
Who it enrols
Patients aged 40-75 with moderate to very severe stable COPD (GOLD stage 2-4) and evidence of muscle wasting.
04
Endpoints
Primary
Change From Baseline in Lean Body Mass
Secondary
Change From Baseline in Exercise Capacity
Change From Baseline in Peripheral Muscle Strength
Change From Baseline in Patient-reported Outcomes
Adverse Events
COPD Exacerbations
Plasma Glucose
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