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
Status: Recruiting
Location: See all (139) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Have a diagnosis of primary hypothyroidism made \>= 12 months prior to Screening.
• Be on continuous thyroid replacement therapy 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 (i.e., within 0.45 - 4.12 mIU/L, inclusive) taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening.
Locations
United States
Alabama
Central Research Associates /ID# 255719
RECRUITING
Birmingham
UAB Hospital /ID# 262565
RECRUITING
Birmingham
California
Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
RECRUITING
Bonita
Facey Medical Foundation - Burbank /ID# 262104
RECRUITING
Burbank
John Muir Medical Center /ID# 257103
RECRUITING
Concord
Diagnamics Inc. /ID# 262680
RECRUITING
Encinitas
Providence - St. Jude Medical Center /ID# 256520
RECRUITING
Fullerton
NorCal Medical Research /ID# 256512
RECRUITING
Greenbrae
Velocity Clinical Research - Huntington Park /ID# 259044
RECRUITING
Huntington Park
Scripps Whittier Diabetes Institute /ID# 259215
RECRUITING
La Jolla
Facey Medical Foundation /ID# 260863
RECRUITING
Mission Hills
Hoag Memorial Hospital Presbyterian /ID# 260990
RECRUITING
Newport Beach
Diabetes Associates Medical Group /ID# 256949
RECRUITING
Orange
Western University of Health Sciences /ID# 262183
RECRUITING
Pomona
Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825
RECRUITING
San Mateo
Care Access - Santa Clarita /ID# 262573
RECRUITING
Santa Clarita
Facey Medical Foundation - Valencia /ID# 262102
RECRUITING
Santa Clarita
Olive View UCLA Medical Center /ID# 259092
RECRUITING
Sylmar
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572
RECRUITING
Torrance
Diablo Clinical Research /ID# 261329
RECRUITING
Walnut Creek
San Fernando Valley Health Institute /ID# 257363
RECRUITING
West Hills
Connecticut
New England Research Associates - Bridgeport /ID# 262184
RECRUITING
Bridgeport
Florida
Innovative Research of West Florida /ID# 257356
RECRUITING
Clearwater
ALL Medical Research /ID# 256748
RECRUITING
Cooper City
Northeast Research Institute (NERI) /ID# 261841
RECRUITING
Fleming Island
Northeast Research Institute (NERI) /ID# 261846
RECRUITING
Fleming Island
The Center for Diabetes and Endocrine Care /ID# 255721
RECRUITING
Fort Lauderdale
Encore Medical Research LLC /ID# 256758
RECRUITING
Hollywood
Baptist Health Research Institute /ID# 260989
RECRUITING
Jacksonville
East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972
RECRUITING
Jacksonville
East Coast Research - Jacksonville /ID# 256971
RECRUITING
Jacksonville
Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147
RECRUITING
Jacksonville
The University of Florida Heal /ID# 257361
RECRUITING
Jacksonville
South Florida Wellness & Clinic /ID# 256513
RECRUITING
Margate
Med Research of Florida /ID# 257837
RECRUITING
Miami
Ocean Blue Medical Research Center, Inc /ID# 260438
RECRUITING
Miami Springs
Adult Medicine of Lake County - Mount Dora /ID# 257371
RECRUITING
Mt. Dora
Suncoast Clinical Research Pasco County /ID# 257018
RECRUITING
New Port Richey
West Orange Endocrinology /ID# 256139
RECRUITING
Ocoee
Suncoast Clinical Research - Palm Harbor /ID# 256741
RECRUITING
Palm Harbor
Comprehensive Medical & Research Center /ID# 261678
RECRUITING
Plantation
Northeast Research Institute - St. Augustine /ID# 261857
RECRUITING
Saint Augustine
Metabolic Research Inst /ID# 255729
RECRUITING
West Palm Beach
Georgia
Atlanta Diabetes Associates /ID# 255736
RECRUITING
Atlanta
Grady Clinical Research Center Grady Memorial Hospital /ID# 258419
RECRUITING
Atlanta
East Coast Institute for Research - Canton /ID# 256974
RECRUITING
Canton
Centricity Research - Endocrine Consultants Research /ID# 255738
RECRUITING
Columbus
Physicians Research Associates, LLC /ID# 255675
RECRUITING
Lawrenceville
East Coast Institute for Research - Macon /ID# 256529
RECRUITING
Macon
Endocrine Research Solutions /ID# 256784
RECRUITING
Roswell
Hawaii
Pacific Diabetes & Endocrine Center /ID# 259030
RECRUITING
Honolulu
Iowa
West Broadway Clinic /ID# 256756
RECRUITING
Council Bluffs
Iowa Diabetes and Endocrinology Research Center /ID# 256750
RECRUITING
West Des Moines
Idaho
Rocky Mountain Clinical Research, LLC /ID# 256753
RECRUITING
Idaho Falls
Illinois
Northwestern University Feinberg School of Medicine /ID# 260677
RECRUITING
Chicago
Kansas
Cotton O'Neil Diabetes & Endocrinology /ID# 256749
RECRUITING
Topeka
Kentucky
L-MARC Research Center /ID# 255733
RECRUITING
Louisville
Robley Rex VA Medical Center /ID# 262569
RECRUITING
Louisville
University of Louisville Hospital /ID# 262568
RECRUITING
Louisville
Louisiana
Pennington Biomedical Research Center /ID# 262390
RECRUITING
Baton Rouge
Nola Care Clinical Research /ID# 260145
RECRUITING
Metairie
Omega Clinical Research /ID# 260162
RECRUITING
Metairie
Massachusetts
Tufts Medical Center /ID# 262974
RECRUITING
Boston
Circle Health Diabetes and Endocrine Center /ID# 270461
RECRUITING
Dracut
NECCR PrimaCare Research, LLC /ID# 256531
COMPLETED
Fall River
Michigan
Metro Detroit Endocrinology Center /ID# 260862
RECRUITING
Dearborn
Michigan Healthcare Professionals /ID# 260859
RECRUITING
Farmington Hills
Elite Clinical Research Center /ID# 256782
RECRUITING
Flint
Missouri
Diabetes and Endocrinology Specialists /ID# 259068
RECRUITING
Chesterfield
University of Missouri Hospital /ID# 262562
RECRUITING
Columbia
Jefferson City Medical Group /ID# 257099
RECRUITING
Jefferson City
Mercy Research - Springfield /ID# 262385
RECRUITING
Springfield
St. Louis University /ID# 262375
RECRUITING
St Louis
Washington University-School of Medicine /ID# 262391
RECRUITING
St Louis
Montana
Billings Clinic /ID# 258316
RECRUITING
Billings
Mercury Street Medical /ID# 259632
RECRUITING
Butte
North Carolina
Physician's East Endocrinology /ID# 256491
RECRUITING
Greenville
Carteret Medical Group /ID# 256869
RECRUITING
Morehead City
Lucas Research /ID# 256127
RECRUITING
Morehead City
Lucas Research /ID# 257061
RECRUITING
Morehead City
Accellacare - Salisbury /ID# 257019
RECRUITING
Salisbury
Accellacare Wilmington /ID# 256744
RECRUITING
Wilmington
Nebraska
Bryan Health Pine Lake Campus /ID# 259638
RECRUITING
Lincoln
Methodist Physicians Clinic /ID# 259276
RECRUITING
Omaha
New Hampshire
Southern New Hampshire Diabetes and Endocrinology /ID# 257841
RECRUITING
Nashua
Nevada
Palm Research Center /ID# 256131
RECRUITING
Las Vegas
Northern Nevada Endocrinology /ID# 259646
RECRUITING
Reno
New York
Albany Medical College- Endocrinology Washington Extension /ID# 256794
RECRUITING
Albany
Research Foundation of SUNY - University of Buffalo /ID# 261019
RECRUITING
Buffalo
NYC Research /ID# 258662
RECRUITING
New York
Endocrine Assc Long Island PC /ID# 257357
RECRUITING
Smithtown
Ohio
Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751
RECRUITING
Canton
Cleveland Clinic - Cleveland /ID# 262392
RECRUITING
Cleveland
The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061
RECRUITING
Columbus
Oklahoma
Lynn Institute of Norman /ID# 256785
RECRUITING
Norman
Lynn Institute of Oklahoma City /ID# 263141
RECRUITING
Oklahoma City
Pennsylvania
Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064
RECRUITING
Feasterville-trevose
Jefferson Health - Roosevelt Boulevard /ID# 256837
RECRUITING
Philadelphia
Thomas Jefferson University Hospital /ID# 256834
RECRUITING
Philadelphia
Guthrie Robert Packer Hospital /ID# 261838
RECRUITING
Sayre
South Carolina
TMA Headlands LLC /ID# 259800
RECRUITING
Myrtle Beach
Carolina Endocrine Associates Llc /ID# 259640
RECRUITING
North Charleston
Palmetto Clinical Research - Summerville /ID# 258845
RECRUITING
Summerville
Tennessee
Chattanooga Medical Research /ID# 257631
RECRUITING
Chattanooga
PMG Research of Knoxville /ID# 256854
RECRUITING
Knoxville
Lifedoc Research /ID# 262975
RECRUITING
Memphis
University of Tennessee Health Science Center /ID# 259825
RECRUITING
Memphis
Mid State Endocrine Associates /ID# 259641
RECRUITING
Nashville
Texas
Texas Diabetes and Endocrinology - Central Austin /ID# 255728
RECRUITING
Austin
Texas Diabetes and Endocrinology - South Austin /ID# 255723
RECRUITING
Austin
Brusco, Corpus Christi, TX /ID# 256746
RECRUITING
Corpus Christi
North TX Endocrine Center /ID# 255737
RECRUITING
Dallas
Research Institute Dallas /ID# 256126
COMPLETED
Dallas
Academy of Diabetes, Thyroid and Endocrine /ID# 255735
RECRUITING
El Paso
Diabetes and Thyroid Center of Ft. Worth /ID# 256781
RECRUITING
Fort Worth
Biopharma Informatic - Houston - Business Center Drive /ID# 256149
RECRUITING
Houston
Endocrine and Psychiatry Cente /ID# 259631
RECRUITING
Houston
Juno Research /ID# 259238
RECRUITING
Houston
PlanIt Research, PLLC /ID# 259221
RECRUITING
Houston
Tekton Research - Irving /ID# 260988
RECRUITING
Irving
Southern Endocrinology Associates /ID# 256795
RECRUITING
Mesquite
Texas Diabetes and Endocrinology /ID# 255722
RECRUITING
Round Rock
Diabetes & Glandular Disease Clinic /ID# 255734
RECRUITING
San Antonio
Northeast Clinical Research of San Antonio, LLC /ID# 256868
RECRUITING
San Antonio
Consano Clinical Research, LLC /ID# 256138
RECRUITING
Shavano Park
Texas Valley Clinical Research /ID# 261476
RECRUITING
Weslaco
Utah
Advanced Research Institute /ID# 259821
RECRUITING
Ogden
Virginia
Virginia Endocrinology Research /ID# 259623
RECRUITING
Chesapeake
Richmond VA Medical Center /ID# 262386
RECRUITING
Richmond
Salem VA Medical Center /ID# 262387
RECRUITING
Salem
Vermont
The University of Vermont Medical Center /ID# 256533
RECRUITING
South Burlington
Washington
Rainier Clinical Research /ID# 255802
RECRUITING
Renton
MultiCare Rockwood Clinic /ID# 255951
RECRUITING
Spokane
MultiCare Institute for Research & Innovation /ID# 255954
RECRUITING
Tacoma
Other Locations
Puerto Rico
Clinical Research Investigator Group, LLC /ID# 263177
RECRUITING
Bayamón
ISIS Clinical Research Center /ID# 263182
RECRUITING
Guaynabo
BRCR Global Puerto Rico /ID# 268231
RECRUITING
San Juan
GCM Medical Group, PSC /ID# 263183
RECRUITING
San Juan
Mindful Medical Research /ID# 263184
RECRUITING
San Juan
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-04-26
Estimated Completion Date: 2028-06
Participants
Target number of participants: 2800
Treatments
Experimental: Group 1
Participants will receive Armour Thyroid for up to 81 weeks.
Experimental: Group 2
Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
Related Therapeutic Areas
Sponsors
Leads: AbbVie