An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease

NCT00939783

Last updated date
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Completion of previous Phase 3 Dimebon study (B1451027).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Have any severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the patient
inappropriate for entry into this study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease
Official Title  ICMJE An Open Label Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon (PF 01913539) In Patients With Alzheimer's Disease
Brief Summary The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.
Detailed Description This study was terminated on May 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well -tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Dimebon
Tablet for oral administration
Other Name: PF-01913539
Study Arms  ICMJE Experimental: Dimebon 20 mg TID
10 mg TID for Week 1, followed by 20 mg TID for remainder of study
Intervention: Drug: Dimebon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 8, 2010)
649
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2009)
750
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completion of previous Phase 3 Dimebon study (B1451027).

Exclusion Criteria:

  • Have any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00939783
Other Study ID Numbers  ICMJE B1451029
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP