Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00171730
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2005-09-13
Brief Title:
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Extension to a Multi-Center Randomized Crossover Open Label Dose Finding Study to Compare the Safety Efficacy and PharmacokineticsPharmacodynamics PKPD Relationship of Multiple Doses of Pasireotide SOM230 200 400 and 600 μg Bid and Doses of Open Label Sandostatin SMS 100 μg Tid in Acromegalic Patients
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acromegaly is a rare serious condition characterized by chronic hypersecretion of growth hormone GH generally caused by a GH-secreting pituitary adenoma The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-002849-12 | EUDRACT_NUMBER | None | None |