CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Pasireotidedrug
Likely dose
Pasireotide 600–900 μg subcutaneously twice dailyAI-extracted
Key inclusion· 2
  • ✓Completion of 15 days of pasireotide treatment in parent study CSOM230B2208 with normalization of 24-hour urinary free cortisol, or ongoing significant clinical benefit if not normalized
  • ✓No unacceptable adverse events or tolerability issues during the original 15-day treatment
Key exclusion· 3
  • ✕Poorly controlled diabetes mellitus with ketoacidosis or HgbA1C >10 since starting parent study
  • ✕Persistent ALT/AST or alkaline phosphatase >2.5× ULN, serum creatinine >2.0× ULN, or serum bilirubin >2× ULN
  • ✕Abnormal coagulation (PT/PTT elevated >30% above normal), WBC <3.0×10⁹/L, Hgb <12 g/dL (females) or <13 g/dL (males), platelets <100×10⁹/L

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

Search/NCT00171951
NCT00171951Phase 2Completed
CompareCT.gov

Extension to a Multicenter, Open-label Study to Assess the Safety and Efficacy of 600 μg SOM230, Administered Subcutaneously, Bid in Patients With Cushing's Disease

Novartis Pharmaceuticals·interventional·Posted Sep 15, 2005·Updated Jun 2, 2021

In Brief

A Phase 2 clinical trial evaluating Pasireotide for Cushing Disease. Completed, enrolled 19 participants across 8 sites in 5 countries.

Detailed Summary

Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and efficacy of pasireotide in participants with Cushing's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushing Disease
CountriesFrance, Germany, Italy, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartAug 13, 2004
Primary CompletionJul 8, 2013
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 20.8 years ago

Interventions

Pasireotidedrug

Pasireotide 600 μg or 900 μg was administered as an SC injection.