CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 331 enrolled
Drug / intervention
Quetiapine Fumarate Extended- Releasedrug
Likely dose
Quetiapine Fumarate Extended- Release 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00640601
NCT00640601Phase 3Completed
CompareCT.gov

A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects With Schizophrenia

AstraZeneca·interventional·Posted Mar 21, 2008·Updated Jun 25, 2012

In Brief

A Phase 3 clinical trial evaluating Quetiapine Fumarate Extended- Release for Schizophrenia. Completed, enrolled 331 participants across 36 sites in 4 countries.

Detailed Summary

A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects with Schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesAustralia, Canada, Hong Kong, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2008
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.3 years ago

Interventions

Quetiapine Fumarate Extended- Releasedrug

Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.