Hypothyroidism
Conditions
Keywords
Hypothyroidism, Armour Thyroid, Synthetic T4
Brief 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.
Interventions
DRUGArmour Thyroid
Oral Capsule or Tablet
DRUGLevothyroxine
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
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 6 months 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response | Week 55 | 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). |
| Number of Participants with Adverse Events (AEs) | Up to approximately 90 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Achieve TSH Response | Week 55 | 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 \[stricter than the one used in the Primary Outcome Measure\]). |
| Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid | Up to approximately 29 weeks | Number of participants needing altered dose conversion from synthetic T4 to Armour Thyroid. |
| Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period | Week 55 | Frequency of dose titrations (0,1,2...) during the DB period among participants who achieved TSH response at the end of the DB period. |
Countries
Puerto Rico, United States
Contacts
Primary ContactABBVIE CALL CENTER
Outcome results
None listed