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Generated: July 16, 2019

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CLINICAL TRIALS PROFILE FOR LEVOTHYROXINE SODIUM

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Clinical Trials for LEVOTHYROXINE SODIUM

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.
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.
NCT00648557 Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label, randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D. Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that 90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200 μg) dose under fasting conditions
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for LEVOTHYROXINE SODIUM

Condition Name

Condition Name for LEVOTHYROXINE SODIUM
Intervention Trials
Healthy 6
Hypothyroidism 2
Hemodialysis 1
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Condition MeSH

Condition MeSH for LEVOTHYROXINE SODIUM
Intervention Trials
Thyroid Diseases 3
Hypothyroidism 3
Non-alcoholic Fatty Liver Disease 1
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Clinical Trial Locations for LEVOTHYROXINE SODIUM

Trials by Country

Trials by Country for LEVOTHYROXINE SODIUM
Location Trials
United States 7
China 2
Belgium 1
Brazil 1
Colombia 1
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Trials by US State

Trials by US State for LEVOTHYROXINE SODIUM
Location Trials
North Dakota 4
District of Columbia 2
Maryland 1
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Clinical Trial Progress for LEVOTHYROXINE SODIUM

Clinical Trial Phase

Clinical Trial Phase for LEVOTHYROXINE SODIUM
Clinical Trial Phase Trials
Phase 4 2
Phase 2 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for LEVOTHYROXINE SODIUM
Clinical Trial Phase Trials
Completed 7
Recruiting 3
Not yet recruiting 2
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Clinical Trial Sponsors for LEVOTHYROXINE SODIUM

Sponsor Name

Sponsor Name for LEVOTHYROXINE SODIUM
Sponsor Trials
Mylan Pharmaceuticals 4
University of California, Irvine 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
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Sponsor Type

Sponsor Type for LEVOTHYROXINE SODIUM
Sponsor Trials
Other 16
Industry 8
NIH 2
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