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Generated: December 15, 2018

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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
NCT00648700 Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® 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 Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy adult volunteers under fasting conditions. 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 levothyroxine.
NCT00648882 Fasting Study of Levothyroxine Sodium Tablets 300 Mcg to Synthroid® Tablets 300 Mcg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600 mcg dose (2 × 300 mcg) administered under fasting conditions.
NCT01189344 Levothyroxine (L-T4) Absorption After Bariatric Surgery Completed University of Sao Paulo N/A Intestinal absorption of levothyroxine (LT4) tablets depends on its dissolution in gastric acid secretion, which is reduced after bariatric interventions. Impaired LT4 absorption due to low gastric dissolution has been reported in patients with atrophic or chronic gastritis. The objective of this study is to evaluate the absorption of LT4 tablets in morbidly obese patients before and after Roux-en-Y bariatric surgery.
NCT01581463 A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects Completed Ipe, LLC Phase 1 Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10 Million in the United States and 80 Million patients world-wide are hypothyroid, usually the result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result from low levels of thyroid hormones (T4 and T3) in the blood due to inadequate thyroid hormone production by the thyroid gland. Every tissue in the body is a thyroid hormone target and hypothyroid symptoms can be debilitating. BCT303 utilizes Liothyronine, Sodium as the active ingredient, the same Liothyronine salt utilized as the active ingredient in currently marketed products. The current "gold standard" for treatment of hypothyroidism are products containing Levothyroxine (T4). T4 is known to be a pro-hormone, converted to the more active hormone T3 by deiodinases in various tissues. Patients on Levothyroxine therapy alone are occasionally not euthyroid as measured by clinical presentation, a condition hypothesized to result from low levels of T3 from inadequate T4 to T3 conversion. In addition, the efficiency of conversion of T4 to T3 is variable and dependent on the patho-physiologic state of the patient. BCT303 contains Liothyronine, Sodium as the active ingredient. This product has a patented formulation and granulation procedure that solves multiple clinical and stability problems associated with T3-based products. Thus, BCT303 is designed to have: 1. Increased shelf stability to ensure the maintenance of claimed dosage. 2. A sustained-release profile to minimize side effects associated with spikes in serum T3 levels. 3. Uniformity of dose between production batches and between tablets.
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
Hypercholesterolemia 1
Non-Alcoholic Fatty Liver Disease 1
Morbid Obesity 1
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Condition MeSH

Condition MeSH for Levothyroxine Sodium
Intervention Trials
Thyroid Diseases 2
Hypothyroidism 2
Neoplasm Metastasis 1
Obesity, Morbid 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
Terminated 2
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Clinical Trial Sponsors for Levothyroxine Sodium

Sponsor Name

Sponsor Name for Levothyroxine Sodium
Sponsor Trials
Mylan Pharmaceuticals 4
Singapore Clinical Research Institute 1
Tecnoquimicas 1
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Sponsor Type

Sponsor Type for Levothyroxine Sodium
Sponsor Trials
Other 15
Industry 8
NIH 1
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