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Clinical Trials/NCT00688532
NCT00688532
Completed
Not Applicable

A Pharmacoepidemiological Study on the Association Between Bicalutamide Treated Prostate Cancer and Risk of Coronary Heart Disease (CHD) and Heart Failure (HF) in the General Practice Research Database (GPRD)

AstraZeneca0 sites5,103 target enrollmentDecember 2007
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
AstraZeneca
Enrollment
5103
Primary Endpoint
Heart Failure
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the general population will be followed- up for two outcomes; CHD including acute myocardial infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD and HF associated with the use of bicalutamide compared to non-use will be estimated.

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
June 2009
Last Updated
13 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least two years enrollment with the general practitioner

Exclusion Criteria

  • Patients with cancer before start date of the study

Outcomes

Primary Outcomes

Heart Failure

Time Frame: From study start 1 Jan 1999 through 31December 2006

Coronary heart disease including acute myocardial infarction and death from CHD

Time Frame: From study start 1 Jan 1999 through 31December 2006

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