Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150449
First received: September 6, 2005
Last updated: July 13, 2006
Last verified: July 2006
History of Changes
  Purpose

Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.


Condition Intervention Phase
Anxiety Neuroses
 Drug: Pregabalin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety Tolerability

Estimated Enrollment: 511
Study Start Date: January 2001
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150449

  Show 142 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00150449     History of Changes
Other Study ID Numbers: 1008-100
Study First Received: September 6, 2005
Last Updated: July 13, 2006
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Anxiety Disorders
Neurotic Disorders
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013