Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients (GLAD)
Tracking Information
Start Date ICMJE | June 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: June 26, 2009) | FEV1 [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00929708 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: June 26, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients |
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Official Title ICMJE | A 4-week, Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group, Multi-centre Study to Assess the Efficacy and Tolerability/Safety of Inhaled AZD3199 Once Daily Compared to 9 μg Formoterol Bid and Placebo in Patients With Moderate to Severe COPD |
Brief Summary | The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Condition ICMJE | COPD |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 500 | ||||||||
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Estimated Completion Date | March 2010 | ||||||||
Primary Completion Date | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 40 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Bulgaria, Canada, Japan, Poland, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00929708 | ||||
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Responsible Party | Carin Jorup, MD, Medical Science Director, Emerging Respiratory 3, AstraZeneca R&D | ||||
Study ID Numbers ICMJE | D0570C00003 | ||||
Study Sponsor ICMJE | AstraZeneca | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | AstraZeneca |
Source: http://clinicaltrials.gov/