CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 198 enrolled
Drug / intervention
Pasireotide +2 moredrug
Likely dose
octreotide LAR 30mgfrom 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/NCT01137682
NCT01137682Phase 3Completed

A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

Novartis Pharmaceuticals·interventional·Posted Jun 4, 2010·Updated Apr 5, 2018

In Brief

A Phase 3 clinical trial evaluating Pasireotide, octreotide LAR 30mg, and 1 other intervention for Acromegaly. Completed, enrolled 198 participants across 60 sites in 18 countries.

Detailed Summary

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesArgentina, Belgium, Brazil, Canada, Colombia, France, Germany, Israel, Italy, Norway, Poland, Romania, Russia, Saudi Arabia, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2010
Enrollment StartJul 19, 2010
Primary CompletionJan 22, 2013
Study CompletionFeb 28, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.1 years ago

Interventions

Pasireotidedrug

* Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or * Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks

octreotide LAR 30mgdrug

In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization

lanreotide ATG 120mgdrug

In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization