Status:
COMPLETED
Sertindole in Asian Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.
Detailed Description
This study is the first randomised clinical trial performed in Asia with sertindole, aiming at comparing sertindole efficacy and safety to that of another atypical antipsychotic. Sertindole is a limb...
Eligibility Criteria
Inclusion
- Male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia
- Positive and Negative Syndrome Scales (PANSS) total score between 60 and 120 (extremes included) at screening and baseline
- Based on the patient's clinical status, an antipsychotic treatment is indicated
- Otherwise healthy
- Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods
Exclusion
- Current Axis I primary psychiatric diagnosis other than schizophrenia
- Has never before received antipsychotic drugs
- Has received a depot antipsychotic medication within less than one dose interval prior to Screening
- History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (\<50 beats per minute)
- Congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females at Screening)
- Significant risk of suicide and/or violent behaviour
- Known history of narrow angle glaucoma
- Substance or alcohol abuse, current alcohol dependence
- Use of disallowed concomitant medication
- Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00864045
Start Date
March 1 2007
End Date
May 1 2008
Last Update
September 20 2013
Active Locations (1)
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1
CN001
Beijing, China, 300074