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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688532
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):

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.

Condition or disease
Prostate Cancer

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Study Type : Observational
Actual Enrollment : 5103 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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)
Study Start Date : December 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Prostate cancer patients treated with bicalutamide or not
General population cohort

Primary Outcome Measures :
  1. Coronary heart disease including acute myocardial infarction and death from CHD [ Time Frame: From study start 1 Jan 1999 through 31December 2006 ]
  2. Heart Failure [ Time Frame: From study start 1 Jan 1999 through 31December 2006 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
GPRD containing computerized information entered by general practitioners in the UK

Inclusion Criteria:

  • At least two years enrollment with the general practitioner

Exclusion Criteria:

  • Patients with cancer before start date of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688532

Sponsors and Collaborators
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Principal Investigator: LA García Rodríguez, MD CEIFE (Centro Español de Investigación Farmacoepidemiológica -Spanish Centre for Pharmacoepidemiologic Research) Almirante

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Responsible Party: AstraZeneca Identifier: NCT00688532    
Other Study ID Numbers: D6874C00008
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Prostate cancer
pharmacoepidemiology study
Additional relevant MeSH terms:
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Prostatic Neoplasms
Heart Failure
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents