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Evaluating the Effect of Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity

NCT00459771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2014-12-02

No results posted yet for this study

Summary

Evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan vs placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab.

Conditions

Interventions

DRUG

AT1 blocker candesartan

AT1 blocker candesartan, 32 mg oral QD

DRUG

Placebo

Placebo, 32 mg, oral QD

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • J.H.M. Schellens, MD PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT00459771 on ClinicalTrials.gov