Study of Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688532
First received: May 30, 2008
Last updated: January 30, 2013
Last verified: January 2013

May 30, 2008
January 30, 2013
December 2007
June 2009   (final data collection date for primary outcome measure)
  • Coronary heart disease including acute myocardial infarction and death from CHD [ Time Frame: From study start 1 Jan 1999 through 31December 2006 ]
  • Heart Failure [ Time Frame: From study start 1 Jan 1999 through 31December 2006 ]
Same as current
Complete list of historical versions of study NCT00688532 on ClinicalTrials.gov Archive Site
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Study of Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not
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)

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

GPRD containing computerized information entered by general practitioners in the UK

Prostate Cancer
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  • 1
    Prostate cancer patients treated with bicalutamide or not
  • 2
    General population cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5103
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least two years enrollment with the general practitioner

Exclusion Criteria:

  • Patients with cancer before start date of the study
Male
50 Years to 84 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00688532
D6874C00008
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: LA García Rodríguez, MD CEIFE (Centro Español de Investigación Farmacoepidemiológica -Spanish Centre for Pharmacoepidemiologic Research) Almirante
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP