A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to assess the safety and effectiveness of the experimental drug, a benzodiazepine drug, in long-term use and the effects on quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.
Full description
This trial is a long-term, open label, safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study, investigators and patients must have first participated in Jazz Pharmaceuticals, Inc. Protocol 04-001-01. The study is designed for four stages that should last a total of 37 weeks.
Sex
Ages
Volunteers
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 abnormalities in health
Exclusion criteria
- Experienced any SAEs (serious adverse events) that were related or possibly related to study drug during participation in Study 04-001-01
- Early termination from study 04-001-01
- Any new condition that could interfere with the evaluation of the subject, interpretation of safety data, or compliance with the protocol requirements
- Experiencing AEs (adverse events) such that in the opinion of the investigator, per protocol, study drug administration or safe participation in this study would be precluded.
- Taken any disallowed medications noted in Study 04-001-01 between the completion of Study 04-001-01 and entry into this trial
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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