Brief Summary

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).

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,165,781

participants targeted

Target at P75+ for all trials

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed

2.5 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed

Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

August 12, 2014

Last Update Submit

August 12, 2014

Conditions

Neoplasm

Outcome Measures

Primary Outcomes (5)

Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs
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
16 years
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics
16 years
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics
16 years
Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs
16 years

Secondary Outcomes (12)

Number of patients with occurrences of lung cancer related to use of ARBs alone
16 years
Number of patients with occurrences of colorectal cancer related to use of ARBs alone
16 years
Number of patients with occurrences of breast cancer related to use of ARBs alone
16 years
Number of patients with occurrences of prostate cancer related to use of ARBs alone
16 years
Number of patients with occurrences of lung cancer related to use of ARBs with ACEI
16 years
+7 more secondary outcomes

Study Arms (1)

Patients prescribed antihypertensives

Drug: ARBDrug: ACEIDrug: Beta-blockersDrug: DiureticsDrug: Telmisartan