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NCT01954056
Phase 3Interventional
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
View on ClinicalTrials.gov ↗Timeline
- Start date
- Jul 1, 2014
- Primary completion
- Oct 1, 2017
- Completion date
- Jul 1, 2018
- First posted
- —
- Last posted
- —
- Enrollment
- 646
- Arms / groups
- 2 / —
- Source
- AACT · pre-existing
Sponsors
- National Institute of Child Health and Human Development (NICHD)Lead sponsor
- Wayne State UniversityOverall official - principal investigator
- Duke UniversityOverall official - principal investigator
- Emory UniversityOverall official - principal investigator
- Indiana UniversityOverall official - principal investigator
- RTI InternationalOverall official - principal investigator
- Stanford UniversityOverall official - principal investigator
- University of PennsylvaniaOverall official - principal investigator
- University of RochesterOverall official - principal investigator
- University of California, Los AngelesOverall official - principal investigator
- University of KansasOverall official - principal investigator
- University of Texas at HoustonOverall official - principal investigator
- Brown UniversityOverall official - principal investigator
- Case Western Reserve UniversityOverall official - principal investigator
- Ohio State UniversityOverall official - principal investigator
- University of New MexicoStudy chair
- National Center for Research Resources (NCRR)Collaborator
- National Institutes of Health (NIH)Collaborator
- University of Alabama, BirminghamOverall official - principal investigator
- University of CincinnatiOverall official - principal investigator
- The University of Texas, DallasOverall official - principal investigator
Drugs studied
Indications studied
CDEK-curated fields only — the ClinicalTrials.gov results mirror (baseline measures, adverse events, participant flow) is a separate, currently-dormant pipeline; see MIGRATION_PLAN.md.