Status:
COMPLETED
Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstruc...
Eligibility Criteria
Inclusion
- Completion of a lead-in study (NCT00891462)
Exclusion
- Use or anticipated use of any medication prohibited in this study
- Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
- The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
- QTcB of \>500 msec on both the pre-dose and post-dose ECG
- Women who are pregnant, intend to become pregnant, or are breast-feeding
- A life expectancy of less than 1 year
- Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
- Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00970268
Start Date
August 1 2009
End Date
October 1 2010
Last Update
January 6 2017
Active Locations (83)
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1
Forest Investigative Site 1162
Birmingham, Alabama, United States, 35209
2
Forest Investigative Site 1127
Mobile, Alabama, United States, 36608
3
Forest Investigative Site 0909
Glendale, Arizona, United States, 85306
4
Forest Investigative Site 2060
Phoenix, Arizona, United States, 85023