AzTrials
AzTrials

NeoplasmNCT02215733

The Use of Angiotensin Receptor Blockers and the Risk of Cancer

An observational study of Neoplasm, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Neoplasm
What is being tested?
ARB, ACEI and Beta-blockers
How many people
1,165,781 participants
Where
No sites listed yet
Study dates
Feb 2011to Feb 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)

Who may be able to join

  • 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)

Who cannot join

  • History of cancer at any time prior to cohort entry

About this study

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).

Conditions
Neoplasm
Being tested
ARB, ACEI, Beta-blockers, Diuretics, Telmisartan
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARBDrug

    other than telmisartan

  • ACEIDrug

  • Beta-blockersDrug

  • DiureticsDrug

  • TelmisartanDrug

Study groups in NCT02215733
Study groupRoleWhat they receive
Patients prescribed antihypertensivesNot described
Receives: Drug: ARB; Drug: ACEI; Drug: Beta-blockers; Drug: Diuretics; Drug: Telmisartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs

    Measured: 16 years

  2. 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

    Measured: 16 years

  3. Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of ARBs, relative to beta-blockers and diuretics

    Measured: 16 years

  4. Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan, relative to beta-blockers and diuretics

    Measured: 16 years

  5. Ratio of occurrence of lung, colorectal, breast and prostate cancers related to use of telmisartan relative to other ARBs

    Measured: 16 years

Secondary outcomes (12)

  1. Number of patients with occurrences of lung cancer related to use of ARBs alone

    Measured: 16 years

  2. Number of patients with occurrences of colorectal cancer related to use of ARBs alone

    Measured: 16 years

  3. Number of patients with occurrences of breast cancer related to use of ARBs alone

    Measured: 16 years

  4. Number of patients with occurrences of prostate cancer related to use of ARBs alone

    Measured: 16 years

  5. Number of patients with occurrences of lung cancer related to use of ARBs with ACEI

    Measured: 16 years

  6. Number of patients with occurrences of colorectal cancer related to use of ARBs with ACEI

    Measured: 16 years

  7. Number of patients with occurrences of breast cancer related to use of ARBs with ACEI

    Measured: 16 years

  8. Number of patients with occurrences of prostate cancer related to use of ARBs with ACEI

    Measured: 16 years

  9. Ratio of occurrence of lung cancer related to use of telmisartan relative to other ARBs

    Measured: 16 years

  10. Ratio of occurrence of colorectal cancer related to use of telmisartan relative to other ARBs

    Measured: 16 years

  11. Ratio of occurrence of breast cancer related to use of telmisartan relative to other ARBs

    Measured: 16 years

  12. Ratio of occurrence of prostate cancer related to use of telmisartan relative to other ARBs

    Measured: 16 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2014 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,165,781 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02215733
Sponsor's protocol ID
502.599
Status last verified
Aug 2014
First submitted
12 Aug 2014
Last updated
13 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasm, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with occurrences of lung, colorectal, breast and prostate cancers related to use of ARBs (time frame: 16 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02215733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in