The 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.
- Subjects with postmenopausal breast cancer (including ovariectomy etc.).
- Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin | |||
| Official Title | Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan) | |||
| Brief Summary | The 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 Description | All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | The patients whom an investigator involving A5991078 prescribes the Exemestane (Aromasin). | |||
| Condition | Breast Neoplasms | |||
| Intervention | Drug: 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/Cohorts | Exemestane 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 Status | Completed | |||
| Actual Enrollment | 451 | |||
| Original Actual Enrollment | 450 | |||
| Actual Study Completion Date | November 2008 | |||
| Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00932165 | |||
| Other Study ID Numbers | A5991078 | |||
| Has Data Monitoring Committee | No | |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | July 2010 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
