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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00703391 |
The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease (COPD) |
Drug: AZD9668 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | A 2-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Tolerability and Pharmacokinetics of Orally Administered AZD9668 in Patients With COPD |
Estimated Enrollment: | 18 |
Study Start Date: | June 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Active Treatment
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Drug: AZD9668
30mg oral tablets twice daily (bid) for 14 days
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2: Placebo Comparator
Placebo Treatment
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Drug: Placebo
Matched placebo to 30mg oral tablet twice daily (bid) for 14 days
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Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca Pharmaceuticals ( Dr.Noel Snell MB FRCP, Medical Science Director, RITA Emerging Project Team ) |
Study ID Numbers: | D0520C00002 |
Study First Received: | June 19, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00703391 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
Chronic obstructive pulmonary lung respiratory disease |
tolerability placebo-controlled pharmacokinetics COPD |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |