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Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
Sponsor: Apsen Farmaceutica S.A.
Summary
The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.
Official title: Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2026-03-26
Completion Date
2027-09-23
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
APSTZD 1
APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1
APSTZD 2
APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1
APSTZD 3
APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1
APSTZD 4
APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1
Stilnox CR®
Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4
Placebo
placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1
Locations (1)
UNIFAG - Casa Nossa Senhora da PAZ -ASF
Bragança Paulista, São Paulo, Brazil