A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants

NCT04124705 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 3014-201-002
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 28

Brief Summary

This study will evaluate the safe and effective dose conversion from levothyroxine (synthetic T4) therapy to Armour Thyroid therapy in participants who are on a stable dose of levothyroxine and have thyroid stimulating hormone (TSH) levels within the normal reference range.

Conditions

Hypothyroidism; Thyroid Disease; Euthyroid; Thyroid Gland; Thyroid Hormones

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Sustained TSH Response

  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.

  End of the titration period (Week 18, 24, 30, or 36) and end of the stabilization period (Week 30, 36, 42, or 48, depending on the length of the titration period).

Secondary Outcomes (1)

• Percentage of Participants With a Titration TSH Response

  End of the titration period (Week 18, 24, 30, or 36)

Study Arms (2)

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).

Drug: Armour® Thyroid

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).

Drug: Levothyroxine

Interventions

Armour® Thyroid DRUG

Administered orally once a day. the daily dose could range from 1/4 - 2 grains.

Also known as: Desiccated thyroid extract, AGN-204771

Armour® Thyroid

Levothyroxine DRUG

Administered orally once a day; the daily dose could range from 25- 200 µg.

Also known as: Synthetic T4

Levothyroxine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have a diagnosis of primary hypothyroidism made ≥ 12 months before study entry (Visit 1).
• Be on continuous thyroid replacement therapy with synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit (Visit 1).
• Be on a stable Food and Drug Administration (FDA)-approved daily dose of synthetic T4 for a minimum of 3 months prior to the Screening Visit (Visit 1). Must enter the study on the same stable dose.
• Have euthyroid status indicated by at least 1 documented TSH value within normal reference range (0.45 - 4.12 mIU/L, inclusive) at a minimum of 6 weeks and maximum of 12 months prior to the Screening Visit (Visit 1). Also have a confirmed TSH value within the normal reference range drawn at the Screening Visit (Visit 1).
• Male and female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (35 days after last dose of study intervention).

You may not qualify if:

• 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 5 years.
• Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, levothyroxine (T4), other thyroid replacement medications, or pork products.
• Have received active treatment with an investigational drug within 30 days or 5 half lives, whichever is longer, of Screening Visit (Visit 1).
• Current enrollment in an investigational drug or device study or participation in such a study within 60 days of entry into this study.

Sponsors & Collaborators

• Allergan: lead

Study Sites (28)

Sponsor Site /ID# 237950

Birmingham, Alabama, 35205, United States

Location

Sponsor Site /ID# 237986

Little Rock, Arkansas, 72209-7040, United States

Location

Sponsor Site /ID# 235210

Greenbrae, California, 94904, United States

Location

Sponsor Site /ID# 235716

Huntington Beach, California, 92648, United States

Location

Sponsor Site /ID# 238120

Sacramento, California, 95821-2123, United States

Location

Sponsor Site /ID# 238026

Santa Clarita, California, 91321, United States

Location

Sponsor Site /ID# 238258

Van Nuys, California, 91405-3605, United States

Location

Sponsor Site/ID# 235866

Denver, Colorado, 80246, United States

Location

Sponsor Site /ID# 235853

Fort Lauderdale, Florida, 33312, United States

Location

Sponsor Site /ID# 236809

West Palm Beach, Florida, 33401, United States

Location

Sponsor Site /ID# 235032

Atlanta, Georgia, 30318, United States

Location

Sponsor Site /ID# 237199

Columbus, Georgia, 31904, United States

Location

Sponsor Site /ID# 238088

Lawrenceville, Georgia, 30046, United States

Location

Sponsor Site /ID# 235714

Lexington, Kentucky, 40503, United States

Location

Sponsor Site /ID# 236701

Louisville, Kentucky, 40213-1014, United States

Location

Sponsor Site /ID# 235202

Asheville, North Carolina, 28803, United States

Location

Sponsor Site/ID# 235204

Greenville, North Carolina, 27834, United States

Location

Sponsor Site /ID# 238023

Hickory, North Carolina, 28601, United States

Location

Sponsor Site /ID# 237137

Austin, Texas, 78731, United States

Location

Sponsor Site/ID# 238071

Austin, Texas, 78749, United States

Location

Sponsor Site/ID# 237652

Dallas, Texas, 75231, United States

Location

Sponsor Site/ID# 237655

Dallas, Texas, 75231, United States

Location

Sponsor Site /ID# 235870

El Paso, Texas, 79935, United States

Location

Sponsor Site /ID# 235860

Round Rock, Texas, 78681, United States

Location

Sponsor Site /ID# 235894

San Antonio, Texas, 78229, United States

Location

Sponsor Site /ID# 235211

Renton, Washington, 98057, United States

Location

Sponsor Site /ID# 236022

Spokane, Washington, 99202, United States

Location

Sponsor Site/ID# 236977

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Hypothyroidism; Thyroid Diseases

Interventions

Thyroid (USP); Thyroxine

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: October 11, 2019
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

US (28)