NCT02468674 - A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study | Biotech Hunter

Enrollment

160

Participants

Timeline

Start Date

July 22, 2015

Primary Completion Date

December 3, 2018

Study Completion Date

December 3, 2018

Conditions

Sarcopenia

Interventions

DRUG

bimagrumab

"bimagrumab low dose bimagrumab moderate dose bimagrumab high dose~Patients enrolled prior to the protocol amendment 1 (Population I ), who received bimagrumab in the core study, entered the extension study at Week 25 and were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Study medication was administered as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45."

DRUG

Placebo

"Placebo~Patients enrolled prior to the protocol amendment 1 (Population I), who received placebo in core study, entered the extension study at Week 25 and received placebo as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45."

Trial Locations (30)

1090

Novartis Investigative Site, Brussels

1211

Novartis Investigative Site, Geneva

2400

Novartis Investigative Site, Copenhagen NV

3021

Novartis Investigative Site, St Albans

11217

Novartis Investigative Site, Taipei

12000

Novartis Investigative Site, Prague

16499

Novartis Investigative Site, Suwon

28905

Novartis Investigative Site, Getafe

29303

Novartis Investigative Site, Spartanburg

30501

Novartis Investigative Site, Gainesville

33014

Novartis Investigative Site, Miami Lakes

33604

Novartis Investigative Site, Pessac

34295

Novartis Investigative Site, Montpellier

53705

Novartis Investigative Site, Madison

78229

Novartis Investigative Site, San Antonio

101990

Novartis Investigative Site, Moscow

117997

Novartis Investigative Site, Moscow

150003

Novartis Investigative Site, Yaroslavl

190068

Novartis Investigative Site, Saint Petersburg

474-8511

Novartis Investigative Site, Ōbu

440-8510

Novartis Investigative Site, Toyohashi

509 6134

Novartis Investigative Site, Mizunami

630-8581

Novartis Investigative Site, Nara

586-8521

Novartis Investigative Site, Kawachi-Nagano

362-0806

Novartis Investigative Site, Kitaadachigun Inamachi

364-8501

Novartis Investigative Site, Kitamoto

173 0015

Novartis Investigative Site, Itabashi Ku

204-0021

Novartis Investigative Site, Kiyose

136-0075

Novartis Investigative Site, Koto-ku

02006

Novartis Investigative Site, Albacete