Status:
COMPLETED
A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability...
Detailed Description
A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 administer...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- females must be of non-childbearing potential
- moderately severe COPD
- Exclusion criteria:
- Subjects with a main diagnosis of asthma
- subjects with poorly controlled COPD
- subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.
Exclusion
Key Trial Info
Start Date :
November 3 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2007
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00372112
Start Date
November 3 2006
End Date
May 10 2007
Last Update
April 2 2018
Active Locations (14)
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1
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
2
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
3
GSK Investigational Site
Rousse, Bulgaria, 7000
4
GSK Investigational Site
Sofia, Bulgaria, 1431