Ignite Creation Date:
2024-05-06 @ 9:00 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02876900
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2016-08-03
Brief Title:
Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia
Sponsor:
Noven Pharmaceuticals Inc
Organization:
Noven Therapeutics
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Fixed-Dose 6-Week In-Patient Study to Assess Efficacy and Safety of HP-3070 in Subjects Diagnosed With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2020-10
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:
HP-3070
Brief Summary:
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia
Detailed Description:
This is a Phase 3 randomized double-blind placebo-controlled in-patient efficacy and safety study to evaluate HP-3070 for the treatment of schizophrenia
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia who are in an acute exacerbation and to assess the impacts of covariates on asenapine exposure as delivered in a patch formulation using a population-based approach
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia who are in an acute exacerbation and to assess the impacts of covariates on asenapine exposure as delivered in a patch formulation using a population-based approach
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