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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,800
Oral Capsule or Tablet
Oral Capsule
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 (inclusive). 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).
Time frame: Week 55
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.
Time frame: Up to approximately 90 weeks
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 \[stricter than the one used in the Primary Outcome Measure\]).
Time frame: Week 55
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.
Time frame: Up to approximately 29 weeks
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.
Time frame: Week 55
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Central Research Associates /ID# 255719
Birmingham, Alabama, United States
RECRUITINGUAB Hospital /ID# 262565
Birmingham, Alabama, United States
RECRUITINGKaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
Bonita, California, United States
RECRUITINGFacey Medical Foundation - Burbank /ID# 262104
Burbank, California, United States
RECRUITINGJohn Muir Medical Center /ID# 257103
Concord, California, United States
RECRUITINGDiagnamics Inc. /ID# 262680
Encinitas, California, United States
RECRUITINGProvidence - St. Jude Medical Center /ID# 256520
Fullerton, California, United States
RECRUITINGNorCal Medical Research /ID# 256512
Greenbrae, California, United States
RECRUITINGVelocity Clinical Research - Huntington Park /ID# 259044
Huntington Park, California, United States
RECRUITINGScripps Whittier Diabetes Institute /ID# 259215
La Jolla, California, United States
RECRUITING...and 129 more locations