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NCT00311987 · ClinicalTrials.gov registry record · Phase 1
Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients
A Phase 1 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00311987: Clinical Trial Phase 1 study, sponsored by Johns Hopkins University.
NCT00311987 is a Phase 1 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00311987, a Phase 1 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by their actions on other organs, including the heart, bone, and brain, where there can be side effects of excessive thyroid hormone action. 3,5-diiodothyropropionic acid (DITPA) is a thyroid hormone analog with relative selectivity for a form of the thyroid hormone receptor expressed in the liver, where it regulates several aspects of lipid metabolism, including the clearance of low-density lipoprotein (LDL) cholesterol. This study is designed to determine whether DITPA is safe and effective in achieving LDL cholesterol levels that are consistent with the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines in patients who have not achieved those levels on conventional therapy, due to drug-resistant disease, drug intolerance, or both. This is a single-center, randomized, double-blind, placebo-controlled study. Following a 4-week Pre-Randomization Phase with dietary counseling and a 2-week placebo run-in, eligible patients will be randomized (1:1:1) to receive DITPA (90 mg/day, 180 mg/day), or placebo for a total treatment duration of 12 weeks. Sixty (60) patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 20 patients per treatment group): * DITPA at 90 mg/day (45 mg twice a day \[BID\] taken orally) * DITPA at 180 mg/day (90 mg BID taken orally) * Placebo (BID taken orally) Those patients randomized to receive DITPA at 90 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for 10 weeks. Those patients randomized to receive DITPA at 180 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for the next 2 weeks, and then 180 mg/day for 8 weeks.
Interventions
- DRUG 3,5-Diiodothyropropionic acid (DITPA) therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-04 |
| Est. Completion | 2007-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00311987
The ClinicalTrials.gov registry entry for NCT00311987 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 3,5-Diiodothyropropionic acid (DITPA) therapy is the first listed.
NCT00311987 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00311987 about?
NCT00311987 is a clinical study titled "Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients". The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by their actions on other organs, including the heart, bone, and brain, where there can be side effects of excessive ...
What is the current status of trial NCT00311987?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2006-04. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00311987?
The interventions under investigation include: 3,5-Diiodothyropropionic acid (DITPA) therapy (DRUG).
Who is sponsoring clinical trial NCT00311987?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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