CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
Pasireotide sub-cutaneousdrug
Likely dose
Pasireotide sub-cutaneous 1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01582061
NCT01582061Phase 3Completed

An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape).

Novartis Pharmaceuticals·interventional·Posted Apr 20, 2012·Updated Jun 19, 2018

In Brief

A Phase 3 clinical trial evaluating Pasireotide sub-cutaneous for Cushing's Disease. Completed, enrolled 104 participants across 65 sites in 11 countries.

Detailed Summary

This study provided access to pasireotide sc in patients with Cushing's disease.and provided additional information for safety and efficacy of pasireotide s.c.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Czechia, Germany, Greece, Lebanon, Romania, Russia, South Korea, Spain, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2012
Enrollment StartAug 16, 2011
Primary CompletionJan 26, 2017
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 14.2 years ago

Interventions

Pasireotide sub-cutaneousdrug

Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg, 600 μg, or 300 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg and 600 μg for glucose impaired metabolism patients