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

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ClinicalTrials.gov Identifier: NCT04124705
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safe and effective dose conversion from synthetic T4 therapy to Armour Thyroid therapy in participants who are euthyroid on a stable dose of synthetic T4.

Condition or disease Intervention/treatment Phase
Hypothyroidism Thyroid Disease Euthyroid Thyroid Gland Thyroid Hormones Drug: Armour® Thyroid Drug: Synthetic T4 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Dose-conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants Who Are Euthyroid on T4 Replacement Therapy
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : July 28, 2021
Estimated Study Completion Date : July 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Armour® Thyroid
Oral administration
Drug: Armour® Thyroid
Oral administration once daily

Active Comparator: Synthetic T4
Oral administration
Drug: Synthetic T4
Oral administration once daily
Other Name: Levothyroxine




Primary Outcome Measures :
  1. The percent of participants who are Sustained Thyroid-Stimulating Hormone (TSH) Responders [ Time Frame: Up to week 48 ]
    Participants whose TSH values are within the normal reference range among participants who received at least 1 dose of study intervention


Secondary Outcome Measures :
  1. The percent of participants who are Titration TSH Responders [ Time Frame: Up to week 48 ]
    Participants whose TSH values are within the normal reference range among participants who received at least 1 dose of study intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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).

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124705


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

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Sponsors and Collaborators
Allergan
Investigators
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Study Director: William Ferguson, PhD Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04124705     History of Changes
Other Study ID Numbers: 3014-201-002
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Diseases
Hypothyroidism
Endocrine System Diseases