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| Sponsored by: |
AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00688532 |
Purpose
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 |
|---|
|
Prostate Cancer |
| Study Type: | Observational |
| Study Design: | Cohort, 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) |
| Estimated Enrollment: | 5000 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2009 |
| Groups/Cohorts |
|---|
|
1
Prostate cancer patients treated with bicalutamide or not
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2
General population cohort
|
Eligibility| Ages Eligible for Study: | 50 Years to 84 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
GPRD containing computerized information entered by general practitioners in the UK
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Principal Investigator: | LA García Rodríguez, MD | CEIFE (Centro Español de Investigación Farmacoepidemiológica -Spanish Centre for Pharmacoepidemiologic Research) Almirante |
More Information
| Responsible Party: | AstraZeneca Pharmaceuticals ( Tom Morris ) |
| Study ID Numbers: | D6874C00008 |
| Study First Received: | May 30, 2008 |
| Last Updated: | June 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00688532 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Prostate cancer pharmacoepidemiology study |
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Arterial Occlusive Diseases Heart Failure Heart Diseases Prostatic Diseases Genital Neoplasms, Male Myocardial Ischemia Vascular Diseases Urogenital Neoplasms |
Ischemia Arteriosclerosis Genital Diseases, Male Coronary Disease Bicalutamide Prostatic Neoplasms Coronary Artery Disease |
|
Neoplasms Neoplasms by Site Cardiovascular Diseases |
