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NCT00032643 · ClinicalTrials.gov registry record · Phase 2
A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)
A Phase 2 study, sponsored by US Department of Veterans Affairs.
- Terminated
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT00032643 is a Phase 2 study that was terminated before completion, run by US Department of Veterans Affairs. The registered enrollment target is 150 participants.
The verdict
NCT00032643, a Phase 2 study, was terminated before completion, sponsored by US Department of Veterans Affairs.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
Congestive heart failure (CHF) affects 4-5 million Americans, and its prevalence is predicted to increase over the next few decades. Thyroid hormone has unique actions which make it a novel and potentially useful agent for treatment of CHF. Due to possible adverse affects of thyroid hormone, there is interest in developing analogs with fewer undesirable side effects. 3,5- diiodothyropropionic acid (DITPA) has been shown to improve diastolic function in both animal models and a recently completed double-blind placebo controlled trial in 19 humans. The goal of the proposed Phase II study is to show safety and demonstrate a medication of efficacy of DITPA needed in patients with CHF. This study is a prerequisite for a larger Phase III trial which would determine whether mortality is improved with DITPA. To better define the appropriate doses, prior to the Phase II study we will conduct an initial pharmacokinetic study.
Interventions
- DRUG DITPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-06 |
| Est. Completion | 2006-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00032643
The ClinicalTrials.gov registry entry for NCT00032643 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DITPA is the first listed.
NCT00032643 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00032643 about?
NCT00032643 is a clinical study titled "A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)". Congestive heart failure (CHF) affects 4-5 million Americans, and its prevalence is predicted to increase over the next few decades. Thyroid hormone has unique actions which make it a novel and potentially useful agent for treatment of CHF. Due to possible adverse affects of thyroid hormone, there i...
What is the current status of trial NCT00032643?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2004-06. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00032643?
The interventions under investigation include: DITPA (DRUG).
Who is sponsoring clinical trial NCT00032643?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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