Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234572
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2005-10-06
Brief Title:
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
Phase II Multicentre Randomized Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel 60 90 or 120mg Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic Pharmacodynamic Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel 60 90 120mg Ending in Open Label Dose Titration Phase
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None