CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 358 enrolled
Drug / intervention
Pasireotide +1 moredrug
Likely dose
Not stated in 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/NCT00600886
NCT00600886Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

Novartis Pharmaceuticals·interventional·Posted Jan 25, 2008·Updated Jul 2, 2017

In Brief

A Phase 3 clinical trial evaluating Pasireotide and Octreotide for Acromegaly. Completed, enrolled 358 participants across 95 sites in 27 countries.

Detailed Summary

The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study was to compare the proportion of patients with a reduction of mean GH level to \<2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months. Following one year of treatment patients could proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesArgentina, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Poland, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2008
Enrollment StartFeb 11, 2008
Primary CompletionMar 11, 2016
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 18.4 years ago

Interventions

Pasireotidedrug

Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.

Octreotidedrug

Octreotide LAR - i.m. depot injection given once every 28 days.