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NCT01601600 · ClinicalTrials.gov registry record · Phase 2
A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults
A Phase 2 study of Skeletal Muscle, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 5
- Study locations
NCT01601600: Completed Phase 2 study of Skeletal Muscle, sponsored by Novartis Pharmaceuticals.
NCT01601600 is a Phase 2 study of Skeletal Muscle that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 40 participants, roughly in line with the 37-participant average among 4 other Skeletal Muscle trials with a reported enrollment target. The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01601600, a Phase 2 study of Skeletal Muscle, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly adults with sarcopenia and mobility limitations. In addition, this study will generate data on the safety, tolerability, and pharmacokinetics of BYM338 in older adults and its response on additional physical function measures in this population. Furthermore, the extended study duration will provide information on the stability of BYM-induced changes in skeletal muscle and patient function in this subgroup of the older population.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BYM338
Study Locations (5)
Arkansas
- Novartis Investigative Site - Hot Springs
- Novartis Investigative Site - Little Rock
Florida
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Miami
Massachusetts
- Novartis Investigative Site - Brighton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01601600 record still lists
NCT01601600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, roughly in line with the 37-participant average among 4 other Skeletal Muscle trials with a reported enrollment target.
The record links to 1 condition, with Skeletal Muscle appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01601600 lists 5 locations in 3 states (Arkansas, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT01601600 about?
NCT01601600 is a clinical study titled "A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults". The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly adults with sarcopenia and mobility limitations. In addition, this study will generate data on the safety, tolerabi...
What is the current status of trial NCT01601600?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2012-01. Estimated completion is 2013-12.
What conditions does trial NCT01601600 study?
This clinical trial studies the following conditions: Skeletal Muscle.
What interventions are being tested in trial NCT01601600?
The interventions under investigation include: Placebo (DRUG), BYM338 (DRUG).
Who is sponsoring clinical trial NCT01601600?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01601600 being conducted?
This trial has 5 study locations across Arkansas, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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