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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00160147
Other study ID # S154.3.016
Secondary ID 2005-003475-20
Status Terminated
Phase Phase 3
First received September 8, 2005
Last updated January 29, 2015
Start date December 2005
Est. completion date January 2008

Study information

Verified date June 2009
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimer's type.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria:

- Diagnosis of dementia of the Alzheimer's type

Exclusion Criteria:

- History of seizure disorder

- Clinically significant electrocardiogram (ECG)

- Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
bifeprunox
One week titration with dose adjustments
Placebo
Placebo

Locations

Country Name City State
Czech Republic Site 803 Litomerice
Czech Republic Site 802 Lnare
Czech Republic Site 804 Praha
Czech Republic Site 805 Skvorec
Czech Republic Site 801 Tabor
Estonia Site 807 Viljandimaa
Estonia Site 806 Voru Maakond
Israel Site 812 Bat Yam
Israel Site 808 Beer Yaakov
Israel Site 811 Hadera
Israel Site 816 Pardes Hana
Israel Site 810 Rehovot
Israel Site 809 Tirat HaCarmel
Poland Site 814 Choroszcz
Poland Site 813 Gdansk
Poland Site 815 Torun
United States Site 934 Atlanta Georgia
United States Site 936 Austin Texas
United States Site 919 Bedford Massachusetts
United States Site 917 Blue Ridge Georgia
United States Site 923 Boston Massachusetts
United States Site 902 Carson California
United States Site 909 Cincinnati Ohio
United States Site 928 Dallas Texas
United States Site 942 Flowood Mississippi
United States Site 929 Hamden Connecticut
United States Site 932 Humboldt Tennessee
United States Site 903 Long Beach California
United States Site 901 Miami Florida
United States Site 914 New Britain Connecticut
United States Site 904 New Orleans Louisiana
United States Site 925 Newnan Georgia
United States Site 907 North Miami Florida
United States Site 931 Norwalk Connecticut
United States Site 908 Oklahoma City Oklahoma
United States Site 916 Oklahoma City Oklahoma
United States Site 941 Olean New York
United States Site 933 Orange City Florida
United States Site 911 Pasadena California
United States Site 935 Philadelphia Pennsylvania
United States Site 912 Phoenix Arizona
United States Site 922 San Marino California
United States Site 910 Santa Ana California
United States Site 905 Shreveport Louisiana
United States Site 906 Shreveport Louisiana
United States Site 927 St. Louis Missouri
United States Site 930 St. Louis Missouri
United States Site 940 St. Louis Missouri
United States Site 921 Staten Island New York
United States Site 918 Waukesha Wisconsin
United States Site 913 Williamsburg Virginia

Sponsors (1)

Lead Sponsor Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czech Republic,  Estonia,  Israel,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Psychiatric Rating Scale (BPRS) Total Score 10 weeks Yes
Secondary Adverse events 10 weeks Yes