Status:
COMPLETED
A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 functio...
Detailed 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 mu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00106860
Start Date
March 1 2005
End Date
March 1 2006
Last Update
January 9 2008
Active Locations (13)
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1
Florida Clinical Research Center
Bradenton, Florida, United States, 34208
2
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
3
Meridien Research
St. Petersburg, Florida, United States, 33709
4
CNS Research Institute (CRI)
Clementon, New Jersey, United States, 08021