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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00363896 |
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Date of registration:
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10/08/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title:
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Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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843 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00363896 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Andorra
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Austria
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Belgium
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Bulgaria
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Czech Republic
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Denmark
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France
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Germany
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Hungary
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Italy
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Netherlands
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Poland
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Romania
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Russian Federation
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Spain
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United Kingdom
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Contacts
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Name:
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Esther Garcia, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and females aged = 40 years with a clinical diagnosis of moderate to severe
stable COPD
Exclusion Criteria:
- History or current diagnosis of asthma, recent respiratory tract infection or acute
COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic
hypertrophy, bladder neck obstruction or narrow-angle glaucoma
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease (COPD)
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Intervention(s)
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Drug: Aclidinium bromide
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Drug: Placebo
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Primary Outcome(s)
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Trough FEV1 (L) at 28 Weeks on Treatment
[Time Frame: Week 28]
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Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment
[Time Frame: Week 12]
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Secondary Outcome(s)
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Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
[Time Frame: 52 weeks]
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Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
[Time Frame: Week 52]
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Secondary ID(s)
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ACCLAIM I
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CT000740
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M/34273/30
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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