At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Paliperidone palmitate 25 mg eq., Paliperidone palmitate 150 mg eq., and 2 other interventions for Schizophrenia. Completed, enrolled 652 participants across 66 sites in 8 countries.
Detailed Summary
The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. in the deltoid muscle followed by either deltoid or gluteal injections for a total of 13 weeks of treatment as compared with placebo in patients with schizophrenia.
Study Details
Timeline
Interventions
Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8, 36, 64
Paliperidone palmitate 150 mg eq. i.m. Days 1, 8, 36, 64
Placebo i.m. Days 1, 8, 36, 64
Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8, 36, 64