Status:

COMPLETED

Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

Lead Sponsor:

Merck KGaA, Darmstadt, Germany

Conditions:

Hypothyroidism

Eligibility:

All Genders

Phase:

PHASE4

Brief Summary

This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Poi...

Eligibility Criteria

Inclusion

  • Suspected hypothyroidism subject
  • Willing to comply with the trial protocol
  • Signed informed consent document

Exclusion

  • Menstrual period, bleeding hemorrhoids, hematuria
  • Drinking or taking aspirin within 48 hours
  • Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
  • Subjects who are unwilling or unable to complete the trial
  • Subjects who do not sign informed consent form

Key Trial Info

Start Date :

October 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2014

Estimated Enrollment :

283 Patients enrolled

Trial Details

Trial ID

NCT01921452

Start Date

October 1 2013

End Date

February 1 2014

Last Update

November 25 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Research site

Shanghai, China