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

StatusActive, Not Recruiting
PhasePhase 2/3
SponsorAbbVie
Started

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Record History

The 50 most recent of 79 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Enrollment target: estimated 2800 to confirmed 2701
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study sites revised (139)
  2. Site details revised at 1 of 139 sitesv78
  3. Study sites revised (139)v77
  4. Study sites: 138 to 139v76
  5. Study sites: 137 to 138v75
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (137)v74
  2. Study sites: 135 to 137
    • Primary completion date: Jun 2028 to Sep 2027
    v73
  3. Site details revised at 6 of 135 sitesv72
  4. Re-verified, no change to tracked fieldsv71
  5. Study sites: 134 to 135v70
  6. Study sites: 133 to 134v69
  7. Study sites: 131 to 133v68
  8. Study sites: 130 to 131v67
  9. Site details revised at 1 of 130 sitesv66
  10. Study sites: 129 to 130v65
  11. Re-verified, no change to tracked fieldsv64
  12. Study sites: 128 to 129v63
  13. Study sites: 127 to 128v62
  14. Study sites: 126 to 127v61
  15. Study sites: 125 to 126v60
  16. Study sites: 124 to 125v59
  17. Study sites: 123 to 124v58
  18. Study sites: 122 to 123
    • Primary and study completion dates: Jun 3, 2028 to Jun 2028
    v57
  19. Study sites: 121 to 122v56
  20. Study sites: 118 to 121v55
  21. Re-verified, no change to tracked fieldsv54
  22. Study sites: 116 to 118v53
  23. Study sites: 107 to 116
    • Eligibility criteria expanded, about 3 words
    v52
  24. Study sites: 105 to 107v51
  25. Study sites: 104 to 105v50
  26. Re-verified, no change to tracked fieldsv49
  27. Site details revised at 2 of 104 sitesv48
  28. Study sites: 103 to 104v47
  29. Study sites: 102 to 103v46
  30. Study sites: 101 to 102v45
  31. Study sites: 99 to 101v44
  32. Study sites: 98 to 99v43
  33. Study sites: 97 to 98v42
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  35. Study sites: 95 to 96v40
  36. Study sites: 93 to 95v39
  37. Study sites: 92 to 93v38
  38. Study sites: 90 to 92v37
  39. Re-verified, no change to tracked fieldsv36
  40. Study sites: 88 to 90v35
  41. Study sites: 86 to 88v34
  42. Study sites: 85 to 86v33
  43. Study sites: 84 to 85v32
  44. Study sites: 83 to 84v31
  45. Study sites: 80 to 83v30
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
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.
Trial Details
NCT Number NCT06345339
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Hypothyroidism
Related terms Hypothyroidism, Thyroid Diseases
Enrollment 2,701 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov