A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

PHASE3CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

December 4, 2012

Primary Completion Date

August 11, 2014

Study Completion Date

September 9, 2014

Conditions
Schizophrenia
Interventions
DRUG

Asenapine

2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually

DRUG

Placebo Asenapine

Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually

DRUG

Olanzapine

5 and 10 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding

DRUG

Placebo Olanzapine

Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT01617187 - A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688) | Biotech Hunter | Biotech Hunter