NCT01374906 - Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease | Biotech Hunter

Enrollment

150

Participants

Timeline

Start Date

November 4, 2011

Primary Completion Date

December 21, 2016

Study Completion Date

December 21, 2016

Conditions

Cushing's Disease

Interventions

DRUG

pasireotide LAR

Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \>1.5xULN unless titration was precluded by safety reasons).

DRUG

SOM230 LAR 30 mg

starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.

DRUG

SOM230 LAR 10 mg

starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.

Trial Locations (82)

11

Novartis Investigative Site, Jesus Maria

18

Novartis Investigative Site, Miraflores

1070

Novartis Investigative Site, Brussels

1090

Novartis Investigative Site, Jette

2650

Novartis Investigative Site, Edegem

3000

Novartis Investigative Site, Leuven

9000

Novartis Investigative Site, Ghent

10029

Mount Sinai School of Medicine Mt. Sinai Medical Center, New York

10117

Novartis Investigative Site, Berlin

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

13385

Novartis Investigative Site, Marseille Cédex 5

14033

Novartis Investigative Site, Caen Cedex9

19104

University of Pennsylvania - Clinical Studies Unit Unniv SC, Philadelphia

20149

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

21287

Pituitary Center, Division of Endocrinology SC, Baltimore

25030

Novartis Investigative Site, Besançon

30322

Emory University School of Medicine/Winship Cancer Institute G2304 - C2301, Atlanta

33604

Novartis Investigative Site, Pessac

34098

Novartis Investigative Site, Istanbul

35128

Novartis Investigative Site, Padua

35340

Novartis Investigative Site, Izmir

41013

Novartis Investigative Site, Seville

46600

Novartis Investigative Site, Alzira

49100

Novartis Investigative Site, Petah Tikva

53226

Medical College of Wisconsin MCW 2, Milwaukee

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

80131

Novartis Investigative Site, Napoli

82110

Novartis Investigative Site, Germering

85381

ClinTriCo, Phoenix

90095

University of California at Los Angeles UCLA Tiverton, Los Angeles

90509

Harbor-UCLA Medical Center LA Biomed, Torrance

91054

Novartis Investigative Site, Erlangen

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

97080

Novartis Investigative Site, Würzburg

97201

Oregon Health & Sciences University DeptofOregonHealth&Sciences(2), Portland

100730

Novartis Investigative Site, Beijing

119296

Novartis Investigative Site, Moscow

199034

Novartis Investigative Site, Saint Petersburg

200025

Novartis Investigative Site, Shanghai

200040

Novartis Investigative Site, Shanghai

400012

Novartis Investigative Site, Mumbai

610041

Novartis Investigative Site, Chengdu

632004

Novartis Investigative Site, Vellore

48109-0944

University of Michigan Comprehensive Cancer Center SC-2, Ann Arbor

37212-3139

Vanderbilt University Medical Center CSOM230G2304, Nashville

98122-4379

Swedish Medical Center Swedish, Seattle

C1232AAC

Novartis Investigative Site, Buenos Aires

X5009BSN

Novartis Investigative Site, Córdoba

60020-181

Novartis Investigative Site, Fortaleza

21941-913

Novartis Investigative Site, Rio de Janeiro

14048-900

Novartis Investigative Site, Ribeirão Preto

05403 000

Novartis Investigative Site, São Paulo

B3H 1V7

Novartis Investigative Site, Halifax

H2L 4M1

Novartis Investigative Site, Montreal

J1N 5N4

Novartis Investigative Site, Sherbrooke

110 029

Novartis Investigative Site, New Delhi

460-0001

Novartis Investigative Site, Nagoya

812-8582

Novartis Investigative Site, Fukuoka

371 8511

Novartis Investigative Site, Maebashi

060-8648

Novartis Investigative Site, Sapporo

650-0017

Novartis Investigative Site, Kobe

783-8505

Novartis Investigative Site, Nankoku

612-8555

Novartis Investigative Site, Kyoto

565-0871

Novartis Investigative Site, Suita

113-8603

Novartis Investigative Site, Bunkyo-ku

105-8470

Novartis Investigative Site, Minato-ku

162-8666

Novartis Investigative Site, Shinjuku-ku

534-0021

Novartis Investigative Site, Osaka

3015 CE

Novartis Investigative Site, Rotterdam

80-952

Novartis Investigative Site, Gdansk

60-355

Novartis Investigative Site, Poznan

00-909

Novartis Investigative Site, Warsaw

50-367

Novartis Investigative Site, Wroclaw

08041

Novartis Investigative Site, Barcelona

06110

Novartis Investigative Site, Diskapi / Ankara

M6 8HD

Novartis Investigative Site, Salford

NR4 7UY

Novartis Investigative Site, Norwich

S5 7AU

Novartis Investigative Site, Sheffield

SO16 6YD

Novartis Investigative Site, Southampton