drugset / Trial / NCT00779506

Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)

NCT00779506

Phase 4 Completed 96 enrolled AstraZeneca
NaSingle-groupOpen-labelTreatment

Summary

This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Timeline

Start
2008-11
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule 400 mg Oral
Subject Quetiapine Small molecule 800 mg Oral

Indications