Study 14 of 78 for search of: Indonesia
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy of Bifeprunox in Patients With Schizophrenia
This study is currently recruiting participants.
Verified by H. Lundbeck A/S, October 2008
Sponsored by: H. Lundbeck A/S
Information provided by: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00704509
  Purpose

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

MedlinePlus related topics: Schizophrenia
Drug Information available for: Quetiapine Quetiapine fumarate Bifeprunox Bifeprunox mesylate
U.S. FDA Resources
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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in PANSS score at the 12-month time point between bifeprunox and quetiapine. Also, responder rate, time to response/withdrawal, global clinical assessments (CGI), assessment of depressive symptoms (CDSS) and health economic assessments. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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
2: Placebo Comparator Drug: Placebo
Encapsulated tablets, orally, 12 weeks
3: Active Comparator Drug: Quetiapine
600 mg daily, encapsulated tablets, orally, 12 months

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Main inclusion criteria

  • The subject has a primary diagnosis of schizophrenia
  • The subject experiences clinically significant symptoms
  • The subject's medication remained stable for 8 weeks prior to screening
  • The subject is currently in the post-acute maintenance phase of his/her disease

Exclusion Criteria:

Main exclusion criteria

  • The subject is at significant risk of suicide
  • The subject is treatment resistant
  • The subject has experienced an acute exacerbation within 8 weeks prior screening
  • The subject is unlikely to comply with the protocol
  • The subject has a current diagnosis or a history of substance abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704509

Contacts
Contact: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Locations
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
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

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

Keywords provided by H. Lundbeck A/S:
Schizophrenia
Antipsychotic
Bifeprunox

Study placed in the following topic categories:
Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009