A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 8, 2005

Last Updated Date

October 12, 2006

Start Date ^†

December 2004

Current Primary Outcome Measures ^†

Effect on exercise tolerance

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00163098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Effect on lung function and quality of life

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD

Official Title ^†

A Multi-Centre, Multinational, Randomized, Double-Blind, Placebo Controlled, Proof Of Concept Trial To Assess The Effects Of A Subject-Optimized Dose Of UK-369,003 On Exercise Capacity In Subjects With Chronic Obstructive Pulmonary Disease

Brief Summary

A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Pulmonary Disease, Chronic Obstructive

Intervention ^†

Drug: UK-369,003

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

136

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

GOLD criteria 2 to 4
10 pack year history of smoking

Exclusion Criteria:

Women of child bearing potential

Gender

Both

Ages

35 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Argentina, Australia, Germany, India, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00163098

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.