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Sponsored by: |
H. Lundbeck A/S |
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Information provided by: | H. Lundbeck A/S |
ClinicalTrials.gov Identifier: | NCT00704509 |
The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Bifeprunox Drug: Placebo Drug: Quetiapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multinational, Randomised, Double-Blind, Fixed-Dose, Bifeprunox Study Combining a 12-Week Placebo-Controlled, Quetiapine-Referenced Phase With a 12-Month Quetiapine-Controlled Phase in Patients With Schizophrenia |
Estimated Enrollment: | 450 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Bifeprunox
20 mg daily, encapsulated tablets, orally, 12 months
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2: Placebo Comparator |
Drug: Placebo
Encapsulated tablets, orally, 12 weeks
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3: Active Comparator |
Drug: Quetiapine
600 mg daily, encapsulated tablets, orally, 12 months
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Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited. In particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning. In the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included. Non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life. The study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase. After this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox. In the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11915A).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Main inclusion criteria
Exclusion Criteria:
Main exclusion criteria
Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Indonesia | |
ID001 | Recruiting |
Jakarta, Indonesia, 10430 | |
ID002 | Recruiting |
Bangli, Indonesia, 80613 | |
ID003 | Recruiting |
Kabupaten Bandung, Indonesia, 40551 | |
Korea, Republic of | |
KR006 | Recruiting |
Seoul, Korea, Republic of, 143-711 | |
KR004 | Recruiting |
Busan, Korea, Republic of, 614-735 | |
KR005 | Recruiting |
Pusan, Korea, Republic of, 602-739 | |
KR001 | Recruiting |
Seoul, Korea, Republic of, 150-713 | |
KR007 | Recruiting |
South Korea, Korea, Republic of, 200-704 | |
Malaysia | |
MY004 | Recruiting |
Kuala Lumpur, Malaysia, 55100 | |
MY001 | Recruiting |
Kuala Lumpur, Malaysia, 50603 | |
MY003 | Recruiting |
Perak, Malaysia, 31250 | |
MY005 | Recruiting |
Johor Bahru, Malaysia, Johor | |
Philippines | |
PH001 | Recruiting |
Mandaluyong City, Philippines, 1553 | |
PH002 | Recruiting |
Manila, Philippines, 1000 | |
PH003 | Recruiting |
Pasig City, Philippines, 1607 | |
PH004 | Recruiting |
Cebu City, Philippines, 6000 | |
PH005 | Recruiting |
Quezon City, Philippines, 0870 | |
Poland | |
PL002 | Recruiting |
Leszno, Poland, 64-100 | |
PL003 | Recruiting |
Lublin, Poland, 20-109 | |
PL004 | Recruiting |
Lodz, Poland, 91-229 | |
PL005 | Recruiting |
Choroszcz, Poland, 16-070 | |
Ukraine | |
UA003 | Recruiting |
Kyiv, Ukraine, 04080 | |
UA004 | Recruiting |
Lviv, Ukraine, 79021 | |
UA011 | Recruiting |
Odessa, Ukraine, 65006 | |
UA006 | Recruiting |
Kharkiv, Ukraine, 61068 | |
UA007 | Recruiting |
Stepanovka, Kherson, Ukraine, 73488 | |
UA008 | Recruiting |
Dnipropetrovsk, Ukraine, 49005 | |
UA009 | Recruiting |
Donetsk, Ukraine, 83037 | |
UA010 | Recruiting |
Vinnitsa, Ukraine, 21018 | |
UA005 | Recruiting |
Poltava, Ukraine, 36024 |
Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Responsible Party: | H. Lundbeck A/S ( H. Lundbeck A/S ) |
Study ID Numbers: | 11916A, EudraCT 2007-001098-27 |
Study First Received: | June 24, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00704509 |
Health Authority: | India: Drugs Controller General of India; Indonesia: National Agency of Drug and Food Control; Malaysia: Ministry of Health; Philippines: Bureau of Food and Drugs; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; South Korea: Korea Food and Drug Administration (KFDA); Ukraine: Ministry of Health |
Schizophrenia Antipsychotic Bifeprunox |
Schizophrenia Quetiapine Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |