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NCT00115349 · ClinicalTrials.gov registry record · Phase 2

Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases

A Phase 2 study, sponsored by Carelon Research.

Terminated
Registry status
Phase 2
Development phase
20
Enrollment target

NCT00115349: Clinical Trial Phase 2 study, sponsored by Carelon Research.

NCT00115349 is a Phase 2 study that was terminated before completion, run by Carelon Research. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00115349, a Phase 2 study, was terminated before completion, sponsored by Carelon Research.

TERMINATED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether left ventricular function improves more rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims include evaluating changes in myocardial iron burden using T2\* and estimating the relative incidence and severity of chelator-induced toxicity.

Primary Outcome

The primary outcome variable is change in left ventricular ejection fraction (blood ejected from the heart into the body) as measured by MRI from baseline to one year. The unit of primary outcome (left ventricular ejection fraction) is the percent of the blood in left ventricle.

Interventions

  • DRUG Deferoxamine
  • DRUG Deferiprone (L1)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2005-06
Est. Completion 2009-04
Phase Phase 2
Carelon Research

50 total trials

Why NCT00115349 stopped before completion

NCT00115349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

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

NCT00115349 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00115349 about?

NCT00115349 is a clinical study titled "Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases". The purpose of this study is to determine whether left ventricular function improves more rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims include evaluating changes in myo...

What is the current status of trial NCT00115349?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2005-06. Estimated completion is 2009-04.

What interventions are being tested in trial NCT00115349?

The interventions under investigation include: Deferoxamine (DRUG), Deferiprone (L1) (DRUG).

Who is sponsoring clinical trial NCT00115349?

This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00115349's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00115349, the US trial registry maintained by the National Library of Medicine. NCT00115349 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.