Clinical Trial: An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape).
Brief Summary: This study will document the safety and efficacy of pasireotide s.c. in patients with Cushing's disease.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Proportion of patients having a drug-related adverse event that is recorded as grade 3 or 4 or as a serious adverse event [ Time Frame: Week 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48 ]
Original Primary Outcome:
Current Secondary Outcome:
- Proportion of patients with mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) [ Time Frame: Baseline, week 12, 24 and 48 ]
- Proportion of patients achieving a reduction of mean UFC ≥ 50% [ Time Frame: Baseline, week 12, 24 and 48 ]
- Change in Cushing's disease clinical signs and symptoms [ Time Frame: Baseline, week 12, 24 and 48 ]
- Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) scores [ Time Frame: Baseline, week 12, 24 and 48 ]
- Change in GH and IGF-I values [ Time Frame: Baseline, week 12, 24 and 48 ]
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: April 12, 2012
Date Started: August 16, 2011
Date Completion:
Last Updated: April 7, 2017
Last Verified: April 2017
