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Non-Interventional Study With Aricept® Evess

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NCT00889603

Last updated on April 4, 2020
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Study Location
Pfizer Investigational Site
Bacau, Jud. Bacau, 600114 Romania
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease, Vascular Dementia
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

- Outpatients (male / female), older than 50 years.

- Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.

- MMSE score between 12 - 24.

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

- Patients with a known hypersensitivity to donepezil clorhydrat, piperidine derivatives
or any of the excipients of Aricept® Evess.

- Patients with severe impaired hepatic function.

- Patients with pre-existing gastrointestinal ulcer disease.

- Patients with the history of bronchial asthma or chronic obstructive lung disease.

- Patients with the history of serious atrioventricular conduction disturbances.

NCT00889603
Pfizer
Completed
Non-Interventional Study With Aricept® Evess

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Descriptive Information
Brief Title Non-Interventional Study With Aricept® Evess
Official Title Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia
Brief Summary The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week length of the study aims to collect data from a large number of patients (n= 400) on the safety and efficacy at the usual dosage of the product providing an overview of Aricept® Evess profile.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patients will be selected from those addressing psychiatrists on an outpatient bases, male / female, older than 50 years, being diagnosed with Alzheimer's Disease and Vascular Dementia, with MMSE score between 12 - 24.
Condition
  • Alzheimer's Disease
  • Vascular Dementia
Intervention Drug: Aricept® Evess

5 mg film-coated orodispersible tablets, 10 mg film-coated orodispersible tablets.

Treatment may be started with 5 mg donepezil/ day (once-a-day dosing) and after four weeks can be titrated to 10 mg/day (once-a-day dosing).
Study Groups/Cohorts 1
Intervention: Drug: Aricept® Evess
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 Completed
Actual Enrollment
 (submitted: April 13, 2010) 		370
Original Estimated Enrollment
 (submitted: April 28, 2009) 		400
Actual Study Completion Date March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Outpatients (male / female), older than 50 years.
  • Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.
  • MMSE score between 12 - 24.

Exclusion Criteria:

  • Patients with a known hypersensitivity to donepezil clorhydrat, piperidine derivatives or any of the excipients of Aricept® Evess.
  • Patients with severe impaired hepatic function.
  • Patients with pre-existing gastrointestinal ulcer disease.
  • Patients with the history of bronchial asthma or chronic obstructive lung disease.
  • Patients with the history of serious atrioventricular conduction disturbances.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Romania
Removed Location Countries  
 
Administrative Information
NCT Number NCT00889603
Other Study ID Numbers A2501065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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