Finger Lakes Clinical Research | Rochester, NY
Status and phase
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About
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP
All 3 substudies will be analyzed independently of each other.
Each substudy individually will consist of a screening period (up to 42 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
Enrollment
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Inclusion criteria
Exclusion criteria
Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Primary purpose
Allocation
Interventional model
Masking
1,074 participants in 3 patient groups, including a placebo group
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Central trial contact
Christine Murphy; Mariana Alvarado
Data sourced from clinicaltrials.gov
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