NCT01098110

6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)

A Multicenter, Randomized, Double-blind, Fixed-dose, 6-week Trial of the Efficacy and Safety of Asenapine Compared With Placebo in Subjects With an Acute Exacerbation of Schizophrenia (Phase 3)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Asenapine 5 mg	Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.
DRUG	Asenapine 10 mg	Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.
DRUG	Placebo	A matching placebo of asenapine sublingual tablet not containing asenapine

Timeline

• Start date: 2010-05-25
• Primary completion: 2014-04-14
• Completion: 2014-04-14
• First posted: 2010-04-02
• Last updated: 2024-06-20
• Results posted: 2015-04-17