NCT02876900

Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: Noven Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Low Dose Asenapine maleate transdermal patch	The study will evaluate low dose Asenapine maleate transdermal patch
DRUG	High Dose Asenapine maleate transdermal patch	The study will evaluate high dose Asenapine maleate transdermal patch
DRUG	Placebo	The study will evaluate placebo transdermal patch.

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-08-24
• Last updated: 2020-10-22
• Results posted: 2020-03-27

Locations

1 site across 1 country: United States