drugset / Trial / NCT00537771

Liver Safety Under Upfront Arimidex vs Tamoxifen

NCT00537771

Phase 4 Completed 384 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelHealth-services research

Summary

The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases. The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.

Timeline

Start
2007-09
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified 1 mg Oral
Comparator Tamoxifen Small molecule 20 mg Oral

Indications