Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients (CERA)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758459
First received: September 23, 2008
Last updated: July 25, 2011
Last verified: July 2011
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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 23, 2008 | ||||||||
| Last Updated Date | July 25, 2011 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of Adverse Events [ Time Frame: all study visits ] [ Designated as safety issue: Yes ] Number of patients who had an Adverse Event |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00758459 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients | ||||||||
| Official Title ICMJE | A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236as an Oral Tablet in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | ||||||||
| Brief Summary | The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments. |
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| Detailed Description | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 74 | ||||||||
| Completion Date | March 2009 | ||||||||
| 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 | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Bulgaria, Finland, Germany, Hungary, Slovakia | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00758459 | ||||||||
| Other Study ID Numbers ICMJE | D4260C00003 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Andrew Lockton, MD, Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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