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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1
Research site
Shanghai, China