Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00254202
• Date of registration: 10/11/2005
• Prospective Registration: No
• Primary sponsor: Vanda Pharmaceuticals
• Public title: Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
• Scientific title: A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Iloperidone in Schizophrenic Patients in Acute Exacerbation Followed by a Long-term Treatment Phase.
• Date of first enrolment: November 2005
• Target sample size: 600
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00254202
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

India, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject with schizophrenia.

- Subject must sign a written consent form.

Exclusion Criteria:

- Clinically significant disease of the heart, kidneys, liver or gastrointestinal
system

- Psychiatric disorder other than schizophrenia



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: active comparator

Drug: iloperidone

Drug: placebo

Primary Outcome(s)

Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome(s)

Pharmacogenetic analysis

Secondary ID(s)

VP-VYV-683-3101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors