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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00163098




Registration number
NCT00163098
Ethics application status
Date submitted
8/09/2005
Date registered
13/09/2005
Date last updated
13/10/2006

Titles & IDs
Public title
A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD
Scientific 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
Secondary ID [1] 0 0
A3711028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UK-369,003

Treatment: Drugs: UK-369,003


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect on exercise tolerance
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Effect on lung function and quality of life
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- GOLD criteria 2 to 4

- 10 pack year history of smoking
Minimum age
35 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women of child bearing potential

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Chermside,
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4032 - Chermside,
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Cordoba
Country [2] 0 0
Argentina
State/province [2] 0 0
Pcia de Tucuman
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fé
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad de Beurnos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Ciudad de Buenos Aires,
Country [7] 0 0
Argentina
State/province [7] 0 0
Ciudad de Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Provincia de Buenos Aires
Country [9] 0 0
Germany
State/province [9] 0 0
Giessen
Country [10] 0 0
Germany
State/province [10] 0 0
Greifestein
Country [11] 0 0
India
State/province [11] 0 0
Kerala
Country [12] 0 0
India
State/province [12] 0 0
Maharashtra
Country [13] 0 0
India
State/province [13] 0 0
Tamilnadu
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Cambridgeshire
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Glasgow
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Newcastle Upon Tyne
Country [17] 0 0
State/province [17] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance
in patients with COPD
Trial website
https://clinicaltrials.gov/show/NCT00163098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications