A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jazz Pharmaceuticals

Criteria

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