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Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin

Last updated on November 13, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with postmenopausal breast cancer (including ovariectomy etc.).

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

- Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).

NCT00932165
Pfizer
Completed
Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin

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Descriptive Information
Brief TitleSpecial Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin
Official TitleSpecial Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan)
Brief SummaryThe objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed DescriptionAll the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving A5991078 prescribes the Exemestane (Aromasin).
ConditionBreast Neoplasms
InterventionDrug: Exemestane
Aromasin® Tablets 25mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dose is 25 mg of exemestane administered orally once daily after a meal."
Other Name: Aromasin
Study Groups/CohortsExemestane
Patients taking Exemestane Tablets.
Intervention: Drug: Exemestane
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: May 25, 2010)
451
Original Actual Enrollment
 (submitted: July 2, 2009)
450
Actual Study Completion DateNovember 2008
Actual Primary Completion DateNovember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects with postmenopausal breast cancer (including ovariectomy etc.).

Exclusion Criteria:

  • Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00932165
Other Study ID NumbersA5991078
Has Data Monitoring CommitteeNo
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 DateJuly 2010

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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