Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06345339 | 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 | PHASE2 | RECRUITING | 2,800 | — | — | Apr 26, 2024 | Jun 1, 2028 | Jan 5, 2026 | 139 | United States, Puerto Rico |
| NCT04124705 | A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants | PHASE2 | COMPLETED | 284 | — | — | Oct 11, 2019 | Jun 22, 2021 | Jun 5, 2024 | 28 | United States |
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).
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.
Sustained TSH response is defined as TSH values that are within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at both the end of Titration Period and the end of the Stabilization Period.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants will receive Armour Thyroid for up to 81 weeks. |
| Group 2 | EXPERIMENTAL | Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. |
| Armour® Thyroid | EXPERIMENTAL | Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of thyroid stimulating hormone (TSH), in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period). |
| Levothyroxine | ACTIVE_COMPARATOR | Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period). |
| Name | Type | Description |
|---|---|---|
| Armour Thyroid | DRUG | Oral Capsule or Tablet |
| Levothyroxine | DRUG | Oral Capsule |
| Armour® Thyroid | DRUG | Administered orally once a day. the daily dose could range from 1/4 - 2 grains. |
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...