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Non-Interventional Study With Aricept® Evess

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NCT00889603

Last updated on November 13, 2019
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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 TitleNon-Interventional Study With Aricept® Evess
Official TitleNon-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThe 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
InterventionDrug: 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/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: April 13, 2010)		370
Original Estimated Enrollment
 (submitted: April 28, 2009)		400
Actual Study Completion DateMarch 2010
Actual Primary Completion DateMarch 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
Ages50 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesRomania
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00889603
Other Study ID NumbersA2501065
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2011

FOR MORE INFORMATION

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1-800-718-1021

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