The Use of Angiotensin Receptor Blockers and the Risk of Cancer

August 12, 2014 updated by: Boehringer Ingelheim
The primary objective of this study was to assess whether angiotensin blockers (ARBs) and telmisartan in particular, are associated with an increased overall risk of the four most common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective was to explore these effects separately for each of the four cancers and in combination with angiotensin-converting-enzyme-inhibitors (ACEIs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1165781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients prescribed an antihypertensive agent between January 1, 1995 and December 31, 2008, with follow-up until December 31, 2010 Information extracted from United Kingdom General Practice Research Database (GPRD)

Description

Inclusion Criteria:

  • Patients prescribed an antihypertensive agent between 01-JAN-1995 and 31-DEC-2008 with at least two years of up-to-standard medical history in United Kingdom's General Practice Research Database (GPRD)

Exclusion Criteria:

  • History of cancer at any time prior to cohort entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients prescribed antihypertensives
Drug: Telmisartan
Drug: ARB
other than telmisartan
Drug: ACEI
Drug: Beta-blockers
Drug: Diuretics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs
Time Frame: 16 years
16 years
Determination of dose-response in terms of ARB duration of use and cumulative dose and the risk of lung, colorectal, breast and prostate cancers combined
Time Frame: 16 years
16 years
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics
Time Frame: 16 years
16 years
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics
Time Frame: 16 years
16 years
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs
Time Frame: 16 years
16 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with occurrences of lung cancer related to use of ARBs alone
Time Frame: 16 years
16 years
Number of patients with occurrences of colorectal cancer related to use of ARBs alone
Time Frame: 16 years
16 years
Number of patients with occurrences of breast cancer related to use of ARBs alone
Time Frame: 16 years
16 years
Number of patients with occurrences of prostate cancer related to use of ARBs alone
Time Frame: 16 years
16 years
Number of patients with occurrences of lung cancer related to use of ARBs with ACEI
Time Frame: 16 years
16 years
Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI
Time Frame: 16 years
16 years
Number of patients with occurrences of breast cancer related to use of ARBs with ACEI
Time Frame: 16 years
16 years
Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI
Time Frame: 16 years
16 years
Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs
Time Frame: 16 years
16 years
Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs
Time Frame: 16 years
16 years
Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs
Time Frame: 16 years
16 years
Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs
Time Frame: 16 years
16 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (ESTIMATE)

August 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.599

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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