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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/12/2004
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163098