Hypothyroidism Clinical Trial
Official title:
A Phase 2/3 Multicenter, Double Blinded, Randomized, Dose-conversion, Active Control Study Examining the Efficacy and Safety of Armour Thyroid Compared to Synthetic T4 for the Treatment of Adults With Primary Hypothyroidism
This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone [TSH]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy.
| Status | Recruiting |
| Enrollment | 2800 |
| Est. completion date | June 3, 2028 |
| Est. primary completion date | June 3, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Have a diagnosis of primary hypothyroidism made >= 12 months prior to Screening. - Be on continuous thyroid replacement therapy with an FDA-approved dose of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit. - Be on a stable FDA-approved daily dose of synthetic T4 prior to the Screening visit, and must be taking synthetic T4 dose of at least 25 mcg at Screening visit. Must enter the study using the same stable dose to determine dose conversion. - Documentation of 1 in-range thyroid-stimulating hormone (TSH) (i.e., within 0.45 - 4.12 mIU/L, inclusive) at Screening and at least 1 additional in range TSH taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening. Exclusion Criteria: - Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4. - History of alcohol or other substance abuse within the previous 2 years prior to the Screening. - Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas Diabetes and Endocrinology - Central Austin /ID# 255728 | Austin | Texas |
| United States | Texas Diabetes and Endocrinology - South Austin /ID# 255723 | Austin | Texas |
| United States | Billings Clinic /ID# 258316 | Billings | Montana |
| United States | Central Research Associates /ID# 255719 | Birmingham | Alabama |
| United States | New England Research Associates - Bridgeport /ID# 262184 | Bridgeport | Connecticut |
| United States | Research Foundation of SUNY - University of Buffalo /ID# 261019 | Buffalo | New York |
| United States | Mercury Street Medical /ID# 259632 | Butte | Montana |
| United States | Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751 | Canton | Ohio |
| United States | East Coast Institute for Research - Canton /ID# 256974 | Canton | Georgia |
| United States | Chattanooga Medical Research /ID# 257631 | Chattanooga | Tennessee |
| United States | Virginia Endocrinology Research /ID# 259623 | Chesapeake | Virginia |
| United States | Innovative Research of West Florida /ID# 257356 | Clearwater | Florida |
| United States | Columbus Regional Research Ins /ID# 255738 | Columbus | Georgia |
| United States | John Muir Medical Center /ID# 257103 | Concord | California |
| United States | ALL Medical Research /ID# 256748 | Cooper City | Florida |
| United States | Brusco, Corpus Christi, TX /ID# 256746 | Corpus Christi | Texas |
| United States | West Broadway Clinic /ID# 256756 | Council Bluffs | Iowa |
| United States | North TX Endocrine Center /ID# 255737 | Dallas | Texas |
| United States | Research Institute Dallas /ID# 256126 | Dallas | Texas |
| United States | Metro Detroit Endocrinology Center /ID# 260862 | Dearborn | Michigan |
| United States | Academy of Diabetes, Thyroid and Endocrine /ID# 255735 | El Paso | Texas |
| United States | Diagnamics Inc. /ID# 262680 | Encinitas | California |
| United States | NECCR PrimaCare Research, LLC /ID# 256531 | Fall River | Massachusetts |
| United States | Northeast Research Institute (NERI) /ID# 261841 | Fleming Island | Florida |
| United States | Northeast Research Institute (NERI) /ID# 261846 | Fleming Island | Florida |
| United States | Elite Clinical Research Center /ID# 256782 | Flint | Michigan |
| United States | The Center for Diabetes and Endocrine Care /ID# 255721 | Fort Lauderdale | Florida |
| United States | Diabetes and Thyroid Center of Ft. Worth /ID# 256781 | Fort Worth | Texas |
| United States | NorCal Medical Research /ID# 256512 | Greenbrae | California |
| United States | Physician's East Endocrinology /ID# 256491 | Greenville | North Carolina |
| United States | Encore Medical Research LLC /ID# 256758 | Hollywood | Florida |
| United States | Biopharma Informatic - Houston - Business Center Drive /ID# 256149 | Houston | Texas |
| United States | Endocrine and Psychiatry Cente /ID# 259631 | Houston | Texas |
| United States | Juno Research /ID# 259238 | Houston | Texas |
| United States | PlanIt Research, PLLC /ID# 259221 | Houston | Texas |
| United States | Rocky Mountain Clinical Research, LLC /ID# 256753 | Idaho Falls | Idaho |
| United States | Tekton Research /ID# 260988 | Irving | Texas |
| United States | East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972 | Jacksonville | Florida |
| United States | East Coast Research - Jacksonville /ID# 256971 | Jacksonville | Florida |
| United States | Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147 | Jacksonville | Florida |
| United States | The University of Florida Heal /ID# 257361 | Jacksonville | Florida |
| United States | Jefferson City Medical Group /ID# 257099 | Jefferson City | Missouri |
| United States | Palm Research Center /ID# 256131 | Las Vegas | Nevada |
| United States | Physicians Research Associates, LLC /ID# 255675 | Lawrenceville | Georgia |
| United States | L-MARC Research Center /ID# 255733 | Louisville | Kentucky |
| United States | East Coast Institute for Research - Macon /ID# 256529 | Macon | Georgia |
| United States | South Florida Wellness & Clinic /ID# 256513 | Margate | Florida |
| United States | Southern Endocrinology Associates /ID# 256795 | Mesquite | Texas |
| United States | Nola Care Clinical Research /ID# 260145 | Metairie | Louisiana |
| United States | Omega Clinical Research /ID# 260162 | Metairie | Louisiana |
| United States | Carteret Medical Group /ID# 256869 | Morehead City | North Carolina |
| United States | Lucas Research /ID# 256127 | Morehead City | North Carolina |
| United States | Lucas Research /ID# 257061 | Morehead City | North Carolina |
| United States | Adult Medicine of Lake County - Mount Dora /ID# 257371 | Mount Dora | Florida |
| United States | Trial Management Associates - Myrtle Beach /ID# 259800 | Myrtle Beach | South Carolina |
| United States | Southern New Hampshire Diabetes and Endocrinology /ID# 257841 | Nashua | New Hampshire |
| United States | Mid State Endocrine Associates /ID# 259641 | Nashville | Tennessee |
| United States | Suncoast Clinical Research Pasco County /ID# 257018 | New Port Richey | Florida |
| United States | NYC Research /ID# 258662 | New York | New York |
| United States | Lynn Institute of Norman /ID# 256785 | Norman | Oklahoma |
| United States | Carolina Endocrine Associates Llc /ID# 259640 | North Charleston | South Carolina |
| United States | West Orange Endocrinology /ID# 256139 | Ocoee | Florida |
| United States | Lynn Institute of Oklahoma City /ID# 263141 | Oklahoma City | Oklahoma |
| United States | Diabetes Associates Medical Group /ID# 256949 | Orange | California |
| United States | Suncoast Clinical Research - Palm Harbor /ID# 256741 | Palm Harbor | Florida |
| United States | Jefferson Health - Roosevelt Boulevard /ID# 256837 | Philadelphia | Pennsylvania |
| United States | Comprehensive Medical & Research Center /ID# 261678 | Plantation | Florida |
| United States | Rainier Clinical Research /ID# 255802 | Renton | Washington |
| United States | Endocrine Research Solutions /ID# 256784 | Roswell | Georgia |
| United States | Texas Diabetes and Endocrinology /ID# 255722 | Round Rock | Texas |
| United States | Northeast Research institute /ID# 261857 | Saint Augustine | Florida |
| United States | Diabetes & Glandular Disease Clinic /ID# 255734 | San Antonio | Texas |
| United States | Northeast Clinical Research of San Antonio, LLC /ID# 256868 | San Antonio | Texas |
| United States | Care Access - Santa Clarita /ID# 262573 | Santa Clarita | California |
| United States | Consano Clinical Research, LLC /ID# 256138 | Shavano Park | Texas |
| United States | Endocrine Assc Long Island PC /ID# 257357 | Smithtown | New York |
| United States | Cotton O'Neil Digestive Health Center /ID# 256749 | Topeka | Kansas |
| United States | Diablo Clinical Research /ID# 261329 | Walnut Creek | California |
| United States | Texas Valley Clinical Research /ID# 261476 | Weslaco | Texas |
| United States | Iowa Diabetes and Endocrinology Research Center /ID# 256750 | West Des Moines | Iowa |
| United States | San Fernando Valley Health Institute /ID# 257363 | West Hills | California |
| United States | Metabolic Research Inst /ID# 255729 | West Palm Beach | Florida |
| United States | Accellacare Wilmington /ID# 256744 | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response | TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L. TSH response will be determined at Week 55 and at a prior visit with no out-of-range TSH values in between (response rate is tested against a specified non-inferiority margin). | Week 55 | |
| Primary | Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to approximately 90 weeks | |
| Secondary | Percentage of Participants who Achieve TSH Response | TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L. TSH response will be determined at Week 55 and at a prior visit with no out-of-range TSH values in between (response rate is tested against a specified non-inferiority margin [stricter than the one used in the Primary Outcome Measure]). | Week 55 | |
| Secondary | Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid | Number of participants needing altered dose conversion from synthetic T4 to Armour Thyroid. | Up to approximately 29 weeks | |
| Secondary | Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period | Frequency of dose titrations (0,1,2...) during the DB period among participants who achieved TSH response at the end of the DB period. | Week 55 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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