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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

617 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-06-30

Brief Summary

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This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.

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Detailed Description

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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

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Low dose Asenapine maleate patch

Low dose asenapine maleate, transdermal patches will be compared against placebo patches.

Group Type EXPERIMENTAL

Low Dose Asenapine maleate transdermal patch

Intervention Type DRUG

The study will evaluate low dose Asenapine maleate transdermal patch

Placebo

Intervention Type DRUG

The study will evaluate placebo transdermal patch.

High dose asenapine maleate patch

High dose asenapine maleate, transdermal patches will be compared against placebo patches.

Group Type EXPERIMENTAL

High Dose Asenapine maleate transdermal patch

Intervention Type DRUG

The study will evaluate high dose Asenapine maleate transdermal patch

Placebo

Intervention Type DRUG

The study will evaluate placebo transdermal patch.

Placebo transdermal patch

Low dose or high dose asenapine maleate transdermal patch will be compared against placebo patches

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The study will evaluate placebo transdermal patch.

Interventions

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Low Dose Asenapine maleate transdermal patch

The study will evaluate low dose Asenapine maleate transdermal patch

Intervention Type DRUG

High Dose Asenapine maleate transdermal patch

The study will evaluate high dose Asenapine maleate transdermal patch

Intervention Type DRUG

Placebo

The study will evaluate placebo transdermal patch.

Intervention Type DRUG

Other Intervention Names

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Transdermal patch Transdermal patch Sham treatment

Eligibility Criteria

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Inclusion Criteria

* Current diagnosis of schizophrenia.
* Subject has PANSS total score ≥80, AND score of 4 or more in at least 2 of the following PANSS items at Screening and at Baseline: conceptual disorganization delusions; hallucinatory behavior; unusual thought content.
* Subjects must be able to wear a transdermal patch for 24 hours.

Exclusion Criteria

* Subject has been diagnosed with schizophrenia less than 6 months prior to Screening Visit.
* Subject has received within 90 days of Screening Visit: electroconvulsive therapy; transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulation treatments
* Subject has experienced acute depressive symptoms within 30 days prior to Screening Visit that requires treatment with an antidepressant, as determined by the Investigator.
* Currently taking clozapine for the treatment of schizophrenia.
* Has hypothyroidism or hyperthyroidism.
* Subject is currently being treated with insulin for diabetes.
* Subject has epilepsy or history of seizures.
* Positive urine pregnancy test.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No