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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00392587 |
The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: GW856553 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD |
Enrollment: | 30 |
Study Start Date: | August 2006 |
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Germany | |
GSK Investigational Site | |
Berlin, Germany, D-14050 | |
Germany, Niedersachsen | |
GSK Investigational Site | |
Hannover, Niedersachsen, Germany, 30625 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Grosshansdorf, Schleswig-Holstein, Germany, 22927 |
Study Director: | GSK Clinical Trials, MD MSc FPPM | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | MKI106209 |
Study First Received: | October 24, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00392587 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Safety Tolerability Pharmacokinetics Pharmacodynamics COPD |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |