NCT01915303 - Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 6, 2014

Primary Completion Date

September 5, 2016

Study Completion Date

September 4, 2019

Conditions

Cushings Disease

Interventions

DRUG

Pasireotide with or without cabergoline

The trial consisted of Pasireotide-untreated patients who started pasireotide 0.6mg twice a day for 8 weeks. If biochemical control was not achieved by the end of the 8 weeks, and the 0.6mg dose is well-tolerated, the dose was increased to 0.9mg twice a day for another 8 weeks. If biochemical control is not achieved, cabergoline was added and patients began combination treatment with cabergoline at the starting dose of 0.5mg once a day for 8 weeks. If biochemical control is still not achieved at the end of the third 8 week period, the dose of cabergoline was increased to 1.0mg once a day. Patients could also immediately start the combination treatment by adding cabergoline 0.5mg once a day at study entry to their current maximal tolerated dose of pasireotide. Patients continued with the combination treatment for 8 weeks. If biochemical control was not not achieved by the end of the 8 week period, the dose of cabergoline was increased to 1mg once a day.

Trial Locations (29)

1062

Novartis Investigative Site, Budapest

1085

Novartis Investigative Site, Budapest

3000

Novartis Investigative Site, Leuven

9000

Novartis Investigative Site, Ghent

14269

Novartis Investigative Site, Mexico City

29010

Novartis Investigative Site, Málaga

34098

Novartis Investigative Site, Istanbul

34270

Novartis Investigative Site, Durango

34899

Novartis Investigative Site, Pendik / Istanbul

35294

University of Alabama at Birmingham The Kirklin Clinic, Birmingham

35340

Novartis Investigative Site, Izmir

46600

Novartis Investigative Site, Alzira

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

62502

Novartis Investigative Site, Wilayah Persekutuan

80131

Novartis Investigative Site, Napoli

91054

Novartis Investigative Site, Erlangen

97239

Oregon Health and Science University SOM230B2411, Portland

110029

Novartis Investigative Site, New Delhi

110111

Novartis Investigative Site, Bogota

632004

Novartis Investigative Site, Vellore

C1280AEB

Novartis Investigative Site, Caba

80030-110

Novartis Investigative Site, Curitiba

21941-913

Novartis Investigative Site, Rio de Janeiro

90560-030

Novartis Investigative Site, Porto Alegre

05403 000

Novartis Investigative Site, São Paulo

106 76

Novartis Investigative Site, Athens

GR 54636

Novartis Investigative Site, Thessaloniki

160 012

Novartis Investigative Site, Chandigarh

3015 GD

Novartis Investigative Site, Rotterdam