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Clinical trial

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (Tacrolimus) Ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD)

NCT02601703 is registered in ClinicalTrials.gov with Glenmark Pharmaceuticals Ltd. India as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (Tacrolimus) Ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD)
Lead sponsor
Glenmark Pharmaceuticals Ltd. India
Phase
Phase 3
Overall status
Completed
Start date
August 31, 2015
Completion date
October 31, 2016
Enrollment
1,110 (actual)
Sites
60

Conditions

As the registry lists them; a condition with its own page is linked.

atopic dermatitis