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Liver Safety Under Upfront Arimidex vs Tamoxifen

NCT00537771 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2013-01-25

Study results available
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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.

Conditions

Interventions

DRUG

Anastrozole

1 mg once daily oral dose

DRUG

Tamoxifen

20 mg once daily oral dose

Sponsors & Collaborators

Principal Investigators

  • Vivian Gu · AstraZeneca

  • Fengping Liang · AstraZeneca

  • Prof. Wang Shenming · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537771 on ClinicalTrials.gov