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

NCT02876900 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2020-10-22

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Noven Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • George Harb, MD, MPH · Noven Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02876900 on ClinicalTrials.gov