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a benzodiazepine drug

Phase 3

Anxiety Disorder | Small molecule | Psychiatry |Jazz Pharmaceuticals plc|Last Updated: Jan 9, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment158
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00106860A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety DisorderPHASE3 COMPLETED 158Mar 1, 2005Mar 1, 2006Jan 9, 200813 United States
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Study Endpoints
Primary Endpoints
Assessment (over 37 additional weeks following the double-blind study) of the safety of the experimental drug in long-term use in subjects with Generalized Anxiety Disorder (GAD)
Secondary Endpoints
Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
a benzodiazepine drugDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites13

Inclusion Criteria: * Complete Study 04-001-01 * Able to take the medication for 9 months * Understand and sign the Informed Consent * Comply with all study-related procedures * Women of child bearing potential must have a confirmed negative urine pregnancy test * Lack of clinically significant abn...

Countries:United States
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