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A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants
Sponsor: AbbVie
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
2800
Start Date
2024-04-26
Completion Date
2028-06
Last Updated
2026-01-05
Healthy Volunteers
No
Conditions
Interventions
Armour Thyroid
Oral Capsule or Tablet
Levothyroxine
Oral Capsule
Locations (139)
Central Research Associates /ID# 255719
Birmingham, Alabama, United States
UAB Hospital /ID# 262565
Birmingham, Alabama, United States
Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
Bonita, California, United States
Facey Medical Foundation - Burbank /ID# 262104
Burbank, California, United States
John Muir Medical Center /ID# 257103
Concord, California, United States
Diagnamics Inc. /ID# 262680
Encinitas, California, United States
Providence - St. Jude Medical Center /ID# 256520
Fullerton, California, United States
NorCal Medical Research /ID# 256512
Greenbrae, California, United States
Velocity Clinical Research - Huntington Park /ID# 259044
Huntington Park, California, United States
Scripps Whittier Diabetes Institute /ID# 259215
La Jolla, California, United States
Facey Medical Foundation /ID# 260863
Mission Hills, California, United States
Hoag Memorial Hospital Presbyterian /ID# 260990
Newport Beach, California, United States
Diabetes Associates Medical Group /ID# 256949
Orange, California, United States
Western University of Health Sciences /ID# 262183
Pomona, California, United States
Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825
San Mateo, California, United States
Care Access - Santa Clarita /ID# 262573
Santa Clarita, California, United States
Facey Medical Foundation - Valencia /ID# 262102
Santa Clarita, California, United States
Olive View UCLA Medical Center /ID# 259092
Sylmar, California, United States
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572
Torrance, California, United States
Diablo Clinical Research /ID# 261329
Walnut Creek, California, United States
San Fernando Valley Health Institute /ID# 257363
West Hills, California, United States
New England Research Associates - Bridgeport /ID# 262184
Bridgeport, Connecticut, United States
Innovative Research of West Florida /ID# 257356
Clearwater, Florida, United States
ALL Medical Research /ID# 256748
Cooper City, Florida, United States
Northeast Research Institute (NERI) /ID# 261841
Fleming Island, Florida, United States
Northeast Research Institute (NERI) /ID# 261846
Fleming Island, Florida, United States
The Center for Diabetes and Endocrine Care /ID# 255721
Fort Lauderdale, Florida, United States
Encore Medical Research LLC /ID# 256758
Hollywood, Florida, United States
East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972
Jacksonville, Florida, United States
The University of Florida Heal /ID# 257361
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
Baptist Health Research Institute /ID# 260989
Jacksonville, Florida, United States
South Florida Wellness & Clinic /ID# 256513
Margate, Florida, United States
Med Research of Florida /ID# 257837
Miami, Florida, United States
Ocean Blue Medical Research Center, Inc /ID# 260438
Miami Springs, Florida, United States
Adult Medicine of Lake County - Mount Dora /ID# 257371
Mt. Dora, Florida, United States
Suncoast Clinical Research Pasco County /ID# 257018
New Port Richey, Florida, United States
West Orange Endocrinology /ID# 256139
Ocoee, Florida, United States
Suncoast Clinical Research - Palm Harbor /ID# 256741
Palm Harbor, Florida, United States
Comprehensive Medical & Research Center /ID# 261678
Plantation, Florida, United States
Northeast Research Institute - St. Augustine /ID# 261857
Saint Augustine, Florida, United States
Metabolic Research Inst /ID# 255729
West Palm Beach, Florida, United States
Grady Clinical Research Center Grady Memorial Hospital /ID# 258419
Atlanta, Georgia, United States
Atlanta Diabetes Associates /ID# 255736
Atlanta, Georgia, United States
East Coast Institute for Research - Canton /ID# 256974
Canton, Georgia, United States
Centricity Research - Endocrine Consultants Research /ID# 255738
Columbus, Georgia, United States
Physicians Research Associates, LLC /ID# 255675
Lawrenceville, Georgia, United States
The Jones Center Clinical Research /ID# 256529
Macon, Georgia, United States
Endocrine Research Solutions /ID# 256784
Roswell, Georgia, United States
Pacific Diabetes & Endocrine Center /ID# 259030
Honolulu, Hawaii, United States
Rocky Mountain Clinical Research, LLC /ID# 256753
Idaho Falls, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 260677
Chicago, Illinois, United States
West Broadway Clinic /ID# 256756
Council Bluffs, Iowa, United States
Iowa Diabetes and Endocrinology Research Center /ID# 256750
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes & Endocrinology /ID# 256749
Topeka, Kansas, United States
University of Louisville Hospital /ID# 262568
Louisville, Kentucky, United States
Robley Rex VA Medical Center /ID# 262569
Louisville, Kentucky, United States
L-MARC Research Center /ID# 255733
Louisville, Kentucky, United States
Pennington Biomedical Research Center /ID# 262390
Baton Rouge, Louisiana, United States
Nola Care Clinical Research /ID# 260145
Metairie, Louisiana, United States
Omega Clinical Research /ID# 260162
Metairie, Louisiana, United States
Tufts Medical Center /ID# 262974
Boston, Massachusetts, United States
Circle Health Diabetes and Endocrine Center /ID# 270461
Dracut, Massachusetts, United States
NECCR PrimaCare Research, LLC /ID# 256531
Fall River, Massachusetts, United States
Metro Detroit Endocrinology Center /ID# 260862
Dearborn, Michigan, United States
Michigan Healthcare Professionals /ID# 260859
Farmington Hills, Michigan, United States
Elite Clinical Research Center /ID# 256782
Flint, Michigan, United States
Diabetes and Endocrinology Specialists /ID# 259068
Chesterfield, Missouri, United States
University of Missouri Hospital /ID# 262562
Columbia, Missouri, United States
Jefferson City Medical Group /ID# 257099
Jefferson City, Missouri, United States
Mercy Research - Springfield /ID# 262385
Springfield, Missouri, United States
St. Louis University /ID# 262375
St Louis, Missouri, United States
Washington University-School of Medicine /ID# 262391
St Louis, Missouri, United States
Billings Clinic /ID# 258316
Billings, Montana, United States
Mercury Street Medical /ID# 259632
Butte, Montana, United States
Bryan Health Pine Lake Campus /ID# 259638
Lincoln, Nebraska, United States
Methodist Physicians Clinic /ID# 259276
Omaha, Nebraska, United States
Palm Research Center /ID# 256131
Las Vegas, Nevada, United States
Northern Nevada Endocrinology /ID# 259646
Reno, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology /ID# 257841
Nashua, New Hampshire, United States
Albany Medical College- Endocrinology Washington Extension /ID# 256794
Albany, New York, United States
Research Foundation of SUNY - University of Buffalo /ID# 261019
Buffalo, New York, United States
NYC Research /ID# 258662
New York, New York, United States
Endocrine Assc Long Island PC /ID# 257357
Smithtown, New York, United States
Physician's East Endocrinology /ID# 256491
Greenville, North Carolina, 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
Accellacare - Salisbury /ID# 257019
Salisbury, North Carolina, United States
Accellacare Wilmington /ID# 256744
Wilmington, North Carolina, United States
Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751
Canton, Ohio, United States
Cleveland Clinic - Cleveland /ID# 262392
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061
Columbus, Ohio, United States
Lynn Institute of Norman /ID# 256785
Norman, Oklahoma, United States
Lynn Institute of Oklahoma City /ID# 263141
Oklahoma City, Oklahoma, United States
Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064
Feasterville-Trevose, Pennsylvania, United States
Thomas Jefferson University Hospital /ID# 256834
Philadelphia, Pennsylvania, United States
Jefferson Health - Roosevelt Boulevard /ID# 256837
Philadelphia, Pennsylvania, United States
Guthrie Robert Packer Hospital /ID# 261838
Sayre, Pennsylvania, United States
TMA Headlands LLC /ID# 259800
Myrtle Beach, South Carolina, United States
Carolina Endocrine Associates Llc /ID# 259640
North Charleston, South Carolina, United States
Palmetto Clinical Research - Summerville /ID# 258845
Summerville, South Carolina, United States
Chattanooga Medical Research /ID# 257631
Chattanooga, Tennessee, United States
PMG Research of Knoxville /ID# 256854
Knoxville, Tennessee, United States
University of Tennessee Health Science Center /ID# 259825
Memphis, Tennessee, United States
Lifedoc Research /ID# 262975
Memphis, Tennessee, United States
Mid State Endocrine Associates /ID# 259641
Nashville, Tennessee, 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
Brusco, Corpus Christi, TX /ID# 256746
Corpus Christi, Texas, United States
North TX Endocrine Center /ID# 255737
Dallas, Texas, United States
Research Institute Dallas /ID# 256126
Dallas, Texas, United States
Academy of Diabetes, Thyroid and Endocrine /ID# 255735
El Paso, Texas, United States
Diabetes and Thyroid Center of Ft. Worth /ID# 256781
Fort Worth, Texas, United States
Juno Research /ID# 259238
Houston, Texas, United States
Biopharma Informatic - Houston - Business Center Drive /ID# 256149
Houston, Texas, United States
PlanIt Research, PLLC /ID# 259221
Houston, Texas, United States
Endocrine and Psychiatry Cente /ID# 259631
Houston, Texas, United States
Tekton Research - Irving /ID# 260988
Irving, Texas, United States
Southern Endocrinology Associates /ID# 256795
Mesquite, Texas, United States
Texas Diabetes and Endocrinology /ID# 255722
Round Rock, Texas, United States
Northeast Clinical Research of San Antonio, LLC /ID# 256868
San Antonio, Texas, United States
Diabetes & Glandular Disease Clinic /ID# 255734
San Antonio, Texas, United States
Consano Clinical Research, LLC /ID# 256138
Shavano Park, Texas, United States
Texas Valley Clinical Research /ID# 261476
Weslaco, Texas, United States
Advanced Research Institute /ID# 259821
Ogden, Utah, United States
The University of Vermont Medical Center /ID# 256533
South Burlington, Vermont, United States
Virginia Endocrinology Research /ID# 259623
Chesapeake, Virginia, United States
Richmond VA Medical Center /ID# 262386
Richmond, Virginia, United States
Salem VA Medical Center /ID# 262387
Salem, Virginia, United States
Rainier Clinical Research /ID# 255802
Renton, Washington, United States
MultiCare Rockwood Clinic /ID# 255951
Spokane, Washington, United States
MultiCare Institute for Research & Innovation /ID# 255954
Tacoma, Washington, United States
Clinical Research Investigator Group, LLC /ID# 263177
Bayamón, Puerto Rico
ISIS Clinical Research Center /ID# 263182
Guaynabo, Puerto Rico
BRCR Global Puerto Rico /ID# 268231
San Juan, Puerto Rico
GCM Medical Group, PSC /ID# 263183
San Juan, Puerto Rico
Mindful Medical Research /ID# 263184
San Juan, Puerto Rico