Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150449
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : July 14, 2006
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Brief Summary:
Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.

Condition or disease Intervention/treatment Phase
Anxiety Neuroses Drug: Pregabalin Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 511 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders
Study Start Date : January 2001
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Pregabalin

Primary Outcome Measures :
  1. Safety Tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have completed the double-blind portion of the preceding trial
  • Completed any protocol specified withdrawal phase and follow-up visits.

Exclusion Criteria:

  • Patient cannot participate if they experienced a serious adverse event or a nonserious, but medically significant adverse event during the preceding efficacy study that was judged to be related to the study medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150449

  Show 137 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00150449     History of Changes
Other Study ID Numbers: 1008-100
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: July 14, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs