Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

PHASE3CompletedINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

July 19, 2010

Primary Completion Date

January 22, 2013

Study Completion Date

February 28, 2017

Conditions
Acromegaly
Interventions
DRUG

Pasireotide

"* Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or~* Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks"

DRUG

octreotide LAR 30mg

In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization

DRUG

lanreotide ATG 120mg

In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization

Trial Locations (60)

2650

Novartis Investigative Site, Edegem

3000

Novartis Investigative Site, Leuven

9000

Novartis Investigative Site, Ghent

10126

Novartis Investigative Site, Torino

11211

Novartis Investigative Site, Riyadh

13005

Novartis Investigative Site, Marseille

16132

Novartis Investigative Site, Genova

21034

Novartis Investigative Site, Dijon

21423

Novartis Investigative Site, Jeddah

22587

Novartis Investigative Site, Hamburg

31000

Novartis Investigative Site, Toulouse

33604

Novartis Investigative Site, Pessac

34662

Novartis Investigative Site, Altunizade

35022

Novartis Investigative Site, Rennes

35340

Novartis Investigative Site, Izmir

41013

Novartis Investigative Site, Seville

44093

Novartis Investigative Site, Saint Herblain - Nantes

48109

University of Michigan, Ann Arbor

49100

Novartis Investigative Site, Petah Tikva

59037

Novartis Investigative Site, Lille

69677

Novartis Investigative Site, Bron

75235

University of Texas Southwestern Medical Center Division of Hematology/Oncolog, Dallas

75571

Novartis Investigative Site, Paris

80131

Novartis Investigative Site, Napoli

80336

Novartis Investigative Site, München

91054

Novartis Investigative Site, Erlangen

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

97080

Novartis Investigative Site, Würzburg

97239

Oregon Health & Science University, Portland

98122

Swedish Neuroscience Institute 550 17th Avenue, Suite 500, Seattle

98125

Novartis Investigative Site, Messina

101990

Novartis Investigative Site, Moscow

111411

Novartis Investigative Site, Bogota

117036

Novartis Investigative Site, Moscow

625023

Novartis Investigative Site, Tyumen

656024

Novartis Investigative Site, Barnaul

89201260

Novartis Investigative Site, Joinville

C1405BCH

Novartis Investigative Site, CABA

BE-B-1200

Novartis Investigative Site, Brussels

60430 370

Novartis Investigative Site, Fortaleza

65020-070

Novartis Investigative Site, São Luís

21941-913

Novartis Investigative Site, Rio de Janeiro

18618-970

Novartis Investigative Site, Botucatu

13083-970

Novartis Investigative Site, Campinas

04038-002

Novartis Investigative Site, São Paulo

05403 000

Novartis Investigative Site, São Paulo

J1H 5N4

Novartis Investigative Site, Sherbrooke

00000

Novartis Investigative Site, Bogotá

Unknown

Novartis Investigative Site, Santiago de Cali

00168

Novartis Investigative Site, Roma

NO-5021

Novartis Investigative Site, Bergen

NO-0379

Novartis Investigative Site, Oslo

80-952

Novartis Investigative Site, Gdansk

60-355

Novartis Investigative Site, Poznan

50 367

Novartis Investigative Site, Wroclaw

011863

Novartis Investigative Site, Bucharest

08035

Novartis Investigative Site, Barcelona

03010

Novartis Investigative Site, Alicante

07070

Novartis Investigative Site, Antalya

PL6 8DH

Novartis Investigative Site, Plymouth

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY