Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
Summary
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.
Timeline
- Start
- 2016-08
- Primary completion
- 2018-06
- Completion
- 2018-06
Outcome
Met primary endpoint
paper Each of the HP-3070 doses demonstrated significant improvement versus placebo at week 6 for the primary and key secondary endpoints. reads as unknown PMID 33326711 ↗
registry High Dose Asenapine Maleate Patch vs Placebo Patch; p = 0.003; Least Square Mean Difference -4.8 (95% CI -8.06 to -1.64) reads as unknown NCT02876900 ↗
registry Low Dose Asenapine Maleate Patch vs Placebo Patch; p <0.001; Least Square Mean Difference -6.6 (95% CI -9.81 to -3.4) reads as unknown NCT02876900 ↗
release “HP-3070, generic name: asenapine maleate, hereinafter referred to as “the investigational product”) achieved the primary endpoint of the Phase III clinical trial in the U.S.” reads as met primary endpoint noven.com ↗
Publications
- Citrome L, Komaroff M, Starling B, Byreddy S, Terahara T, Hasebe M. Efficacy of HP-3070, an Asenapine Transdermal System, on Symptoms of Hostility in Adults With Schizophrenia: A Post Hoc Analysis of a 6-Week Phase 3 Study. J Clin Psychiatry. 2022 Jun 6;83(4):21m14355. doi: 10.4088/JCP.21m14355.
- Citrome L, Walling DP, Zeni CM, Starling BR, Terahara T, Kuriki M, Park AS, Komaroff M. Efficacy and Safety of HP-3070, an Asenapine Transdermal System, in Patients With Schizophrenia: A Phase 3, Randomized, Placebo-Controlled Study. J Clin Psychiatry. 2020 Dec 15;82(1):20m13602. doi: 10.4088/JCP.20m13602.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asenapine | Other / unclassified | 3.8 mg | Other |
| Subject | Asenapine | Other / unclassified | 7.6 mg | Other |