Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01601600
The ClinicalTrials.gov registry entry for NCT01601600 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 37-participant average among 4 other Skeletal Muscle trials with a reported enrollment target. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Skeletal Muscle
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Therapy and Exercise Training in People With Obesity
RECRUITING · NA
-
Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse
RECRUITING · NA
-
Vascular Dysfunction During Physical Inactivity
COMPLETED · NA
-
A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism
COMPLETED · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.