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NCT00895414 · ClinicalTrials.gov registry record · NA

Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer

A NA study, sponsored by Masonic Cancer Center, University of Minnesota.

Completed
Registry status
NA
Development phase
19
Enrollment target

NCT00895414: Completed NA study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT00895414 is a NA study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00895414, a NA study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.

COMPLETED
Registry status
NA
Development phase
19 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Enalapril maleate may help protect heart cells from the side effects of chemotherapy. It is not yet known whether giving enalapril maleate before or after doxorubicin hydrochloride is more effective in treating women with breast cancer. PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with doxorubicin hydrochloride to see how well it works in treating women with breast cancer.

Primary Outcome

Doxorubicin plasma concentration (DPC) is the primary pharmacokinetic (PK) measure of the exposure. Each patient will have serial PKs performed twice - once with enalapril and once without enalapril. A mean increase or decrease of more than 115 ng/ml in DPC will be considered significant.

Interventions

  • DRUG doxorubicin hydrochloride
  • DRUG enalapril maleate

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2009-04
Est. Completion 2015-10
Phase NA

What the finished NCT00895414 record still lists

NCT00895414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which doxorubicin hydrochloride is the first listed.

NCT00895414 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00895414 about?

NCT00895414 is a clinical study titled "Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Enalapril maleate may help protect heart cells from the side effects of chemotherapy. It is not yet known...

What is the current status of trial NCT00895414?

This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2009-04. Estimated completion is 2015-10.

What interventions are being tested in trial NCT00895414?

The interventions under investigation include: doxorubicin hydrochloride (DRUG), enalapril maleate (DRUG).

Who is sponsoring clinical trial NCT00895414?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00895414's enrollment target sits among peer trials

19 1861st of 2000 higher than 138 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00895414, the US trial registry maintained by the National Library of Medicine. NCT00895414 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.