A 26-week extension to a 26-week treatment, multicenter, randomized, double-blind, placebo-controlled, adaptive, seamless, parallel-group study to assess safety, tolerability and efficacy of two doses of indacaterol (150 and 300 µg o.d.) in patients with chronic obstructive pulmonary disease.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2008-000663-42-SE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 417
Details of inclusion criteria for the core study B2335S can be found in the core study protocol.
Patients eligible to participate in the study extension, by definition, will have met the inclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
In addition the following inclusion criteria specified below must be met.
1.Patients must complete Stage 2 of the core study B2335S.
2.Written informed consent to participate in the extension must be obtained.
3.Patients must be able to comply with all study requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Details of exclusion criteria for the core study B2335S can be found in the core study protocol.
In addition the following exclusion criteria specified below must be met.
1.Patients who were randomized to open-label tiotropium in Study B2335S.
2.Patients who participated in Stage 1 of the core study (B2335S).
3.Patients discontinued irrespective of the reason from Stage 2 of the core study.
4.Patients who fail to comply with the core protocol requirements and procedures.
5.Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
6.Patients who in the Investigator’s opinion should not-participate in the extension study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method