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

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

July 13, 2006

Start Date ^ICMJE

January 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Safety Tolerability

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00150449 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anxiety Neuroses

Intervention ^ICMJE

Drug: Pregabalin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

511

Completion Date

March 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Belgium, Estonia, France, Germany, Israel, Italy, Latvia, Netherlands, Poland, South Africa, Spain, Ukraine, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00150449

Other Study ID Numbers ^ICMJE

1008-100

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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