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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR SYNTHROID

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Clinical Trials for Synthroid

Trial ID Title Status Sponsor Phase Summary
NCT00311987 Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients Terminated Johns Hopkins University Phase 1/Phase 2 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.
NCT00403390 Generic vs. Name-Brand Levothyroxine Completed Boston Children’s Hospital Phase 3 This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.
NCT00488644 Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors Terminated M.D. Anderson Cancer Center N/A Primary Objectives: 1. Assess whether combined treatment with Levothyroxine and Liothyronine improves learning and memory. 2. Explore the relationship between T3 treatment and other domains of cognitive function, quality of life, and mood.
NCT00647855 Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose pharmacokinetic parameters for baseline corrected total L-thyroxine and non-baseline corrected total L-triiodothyronine were calculated using noncompartmental techniques.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Synthroid

Condition Name

Condition Name for Synthroid
Intervention Trials
Hypothyroidism 5
Healthy 3
Subclinical Hypothyroidism 2
Primary Hypothyroidism. 1
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Condition MeSH

Condition MeSH for Synthroid
Intervention Trials
Hypothyroidism 8
Thyroid Diseases 1
Brain Neoplasms 1
Congenital Hypothyroidism 1
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Clinical Trial Locations for Synthroid

Trials by Country

Trials by Country for Synthroid
Location Trials
United States 12
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Trials by US State

Trials by US State for Synthroid
Location Trials
North Dakota 3
Pennsylvania 2
Maryland 2
New York 1
Colorado 1
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Clinical Trial Progress for Synthroid

Clinical Trial Phase

Clinical Trial Phase for Synthroid
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Synthroid
Clinical Trial Phase Trials
Completed 4
Recruiting 4
Terminated 2
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Clinical Trial Sponsors for Synthroid

Sponsor Name

Sponsor Name for Synthroid
Sponsor Trials
Mylan Pharmaceuticals 3
Walter Reed National Military Medical Center 1
Charite University, Berlin, Germany 1
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Sponsor Type

Sponsor Type for Synthroid
Sponsor Trials
Other 10
Industry 3
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Argus Health
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