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Pasireotide in Cushing's Disease
NCT00434148Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2006
- Primary completion
- Mar 2010
- Countries
- 18
- Sponsor
- Novartis
- Modality
- Peptides, Small Molecules
- Drugs
- pasireotide LAR
- Conditions
- Cushing's disease (CD)
01
Overview
Phase 3, randomised, double-blind trial of pasireotide LAR in Cushing's disease (CD) (2 arms), sponsored by Novartis. Primary endpoint: Number of mUFC (Urinary Free Cortisol) Responders at 6 months. Started Dec 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Pasireotide 600 ug
600 ug sc bid, possible escalation to 900 ug
Pasireotide 900 ug
900 ug sc bid, possible escalation to 1200 ug
03
Who it enrols
Adult patients with confirmed ACTH-dependent Cushing's disease who are not candidates for surgery, with elevated UFC, and no recent pituitary irradiation.
04
Endpoints
Primary
Number of mUFC (Urinary Free Cortisol) Responders
Secondary
Change From Baseline in mUFC
Time to First UFC Response
Percent Change From Baseline in Serum Cortisol
Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)
Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure
Mean Change From Baseline in Body Mass Index
Change From Baseline in Tumor Volume
Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score
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