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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
UK-369,003
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: GOLD criteria 2 to 4 10 pack year history of smoking Exclusion Criteria: Women of child bearing potential

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Effect on exercise tolerance

Secondary Outcome Measures

Effect on lung function and quality of life

Full Information

First Posted
September 8, 2005
Last Updated
October 12, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00163098
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
136 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
UK-369,003
Primary Outcome Measure Information:
Title
Effect on exercise tolerance
Secondary Outcome Measure Information:
Title
Effect on lung function and quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: GOLD criteria 2 to 4 10 pack year history of smoking Exclusion Criteria: Women of child bearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Ciudad de Cordoba
State/Province
Cordoba
ZIP/Postal Code
CP 5016
Country
Argentina
Facility Name
Pfizer Investigational Site
City
San Miguel de Tucuman
State/Province
Pcia de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Pfizer Investigational Site
City
San Miguel de Tucuman
State/Province
Pcia de Tucuman
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Rosario
State/Province
Santa Fé
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1272
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1427
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Ciudad de Beurnos Aires
ZIP/Postal Code
C1425DQi
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Ciudad de Buenos Aires,
ZIP/Postal Code
(C1425DTG)
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1115AAB
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1416DRV
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Provincia de Buenos Aires
ZIP/Postal Code
(1605)
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Pfizer Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Pfizer Investigational Site
City
Chermside,
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Pfizer Investigational Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Pfizer Investigational Site
City
Greifestein
ZIP/Postal Code
35753
Country
Germany
Facility Name
Pfizer Investigational Site
City
Cochin
State/Province
Kerala
ZIP/Postal Code
682026
Country
India
Facility Name
Pfizer Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400016
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 019
Country
India
Facility Name
Pfizer Investigational Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600116
Country
India
Facility Name
Pfizer Investigational Site
City
Vellore
State/Province
Tamilnadu
ZIP/Postal Code
632002
Country
India
Facility Name
Pfizer Investigational Site
City
Papworth Everard
State/Province
Cambridgeshire
ZIP/Postal Code
CB3 8RE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711028&StudyName=A+Study+of+UK%2D369%2C003+on+the+Safety+and+Efficacy+in+Patients+with+COPD+
Description
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A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD

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