Status:
COMPLETED
ATAC - Pharmacokinetics (PK) Sub-Protocol
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
Brief Summary
To assess the effect of ARIMIDEX on the pharmacokinetics of tamoxifen and the effects of tamoxifen on the pharmacokinetics of ARIMIDEX..
Eligibility Criteria
Inclusion
- Eligible for entry into the main ATAC trial 1033IL/0029
- Patients must have been taking ATAC trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main ATAC study)
- Patients should be taking their medication in the mornings for at least 3 months
- Patients must be 100% compliant over the preceding fourteen days
Exclusion
- Excluded from entry into the main ATAC trial (1033IL/0029)
- Patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. These include ketoconazole (antifungal) or related compounds
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1999
Estimated Enrollment :
9358 Patients enrolled
Trial Details
Trial ID
NCT00784862
Start Date
June 1 1998
End Date
March 1 1999
Last Update
May 15 2009
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