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

Completed · Phase 3

Conditions studied: Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT00106860

Run by

Jazz Pharmaceuticals

People needed

158

Starts

2005-03-01

Expected to finish

2006-03-01

Last updated by the study team

2008-01-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Clinical Research Center — Bradenton, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• CNS Research Institute (CRI) — Clementon, New Jersey, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Neurology and NeuroscienceCenter of Ohio — Toledo, Ohio, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• Oregon Center for Clinical Research, Inc. — Eugene, Oregon, United States
• Suburban Research Associates — Media, Pennsylvania, United States
• CNS Research Institute (CRI) — Philadelphia, Pennsylvania, United States
• Future Search Trials — Austin, Texas, United States
• Comprehensive Neuroscience of Northern Virginia — Falls Church, Virginia, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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