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Lanreotide Autogel in Acromegaly
NCT00234572Phase 3
Key facts
- Status
- Completed
- Start
- May 2000
- Primary completion
- Jan 2003
- Countries
- 8
- Sponsor
- Ipsen
- Modality
- Peptides
- Drugs
- lanreotide
- Conditions
- acromegaly
01
Overview
Phase 3, randomised, double-blind trial of lanreotide in acromegaly (4 arms), sponsored by Ipsen. Primary endpoint: Mean serum GH levels at 52 weeks. Started May 2000; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Lanreotide 60mg
Lanreotide Autogel 60mg
Lanreotide 90mg
Lanreotide Autogel 90mg
Lanreotide 120mg
Lanreotide Autogel 120mg
Placebo
Placebo injection
03
Who it enrols
Patients with active acromegaly, either naive or previously treated with somatostatin analogs (other than lanreotide autogel) or dopaminergic agonists, with elevated GH levels.
04
Endpoints
Primary
Mean serum GH levels
Secondary
Serum IGF-1 levels
05
Results
Primary endpoints met
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