Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia
NCT ID: NCT01963598
Last Updated: 2016-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
253 participants
INTERVENTIONAL
2013-11-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Dosing regimen 1
REGN1033 (SAR391786)
Group 2
Dosing regimen 2
REGN1033 (SAR391786)
placebo
Group 3
Dosing regimen 3
REGN1033 (SAR391786)
placebo
Group 4
Dosing regimen 4
placebo
Interventions
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REGN1033 (SAR391786)
placebo
Eligibility Criteria
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Inclusion Criteria
2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions
3. Ability to follow a walking program
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide signed informed consent
6. Able to understand and complete study-related questionnaires
Exclusion Criteria
2. Surgical procedure requiring general anesthesia within 1 month prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months
3. Participate in resistance training more than 3 times per week and regular exercise consisting of an average of 30 minutes per day or more of at least moderate physical activity
4. Chronic medications introduced within 2 weeks prior to screening
5. Respiratory disease that requires oxygen treatment
6. Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer)
7. Neurological conditions that are causing impaired muscle function or mobility
8. Certain cardiovascular conditions
9. Uncontrolled diabetes
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Anniston, Alabama, United States
Phoenix, Arizona, United States
El Cajon, California, United States
Garden Grove, California, United States
Laguna Hills, California, United States
San Francisco, California, United States
Walnut Creek, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
Chicago, Illinois, United States
Baton Rouge, Louisiana, United States
College Park, Maryland, United States
Elkridge, Maryland, United States
Boston, Massachusetts, United States
Edina, Minnesota, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
High Point, North Carolina, United States
Winston-Salem, North Carolina, United States
Athens, Ohio, United States
Columbus, Ohio, United States
Duncansville, Pennsylvania, United States
Spartanburg, South Carolina, United States
Dallas, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Richmond, Virginia, United States
Limoges, , France
Montpellier, , France
Saint-Etienne, , France
Toulouse, , France
Amsterdam, , Netherlands
Leeuwarden, , Netherlands
Noord-Brabant, , Netherlands
Albacete, , Spain
L'Hospitalet de Llobregat, , Spain
Madrid, , Spain
Countries
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Other Identifiers
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R1033-SRC-1239
Identifier Type: -
Identifier Source: org_study_id
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