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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00570778 |
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: QVA149 Drug: Indacaterol Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) |
Estimated Enrollment: | 140 |
Study Start Date: | December 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator | Drug: QVA149 |
2: Active Comparator | Drug: Indacaterol |
3: Active Comparator | Drug: Indacaterol |
4: Placebo Comparator | Drug: placebo |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
United States, Missouri | |
Novartis Investigator Site | |
St Louis, Missouri, United States | |
United States, North Carolina | |
Novartis Investigator site | |
Raleigh, North Carolina, United States | |
Novartis Investigator Site | |
Charlotte, North Carolina, United States | |
Belgium | |
Novartis Investigator Site | |
Antwerpen, Belgium | |
Novartis Investigator Site | |
Gent, Belgium | |
Novartis Investigator Site | |
Gembloux, Belgium | |
Novartis Investigator Site | |
Saint Vith, Belgium | |
Canada | |
Novartis Investigator Site | |
Montreal, Canada | |
Novartis Investigator site | |
Toronto, Canada | |
Germany | |
Novartis Investigator Site | |
Bad Worishofen, Germany | |
Novartis Investigator Site | |
Berlin, Germany | |
Novartis Investigator Site | |
Frankfurt, Germany | |
Novartis Investigator Site | |
Mainz, Germany | |
Novartis Investigator Site | |
Rudersdorf, Germany | |
Novartis Investigator Site | |
Wiesbaden, Germany | |
Netherlands | |
Novartis Investigator Site | |
Almelo, Netherlands | |
Novartis Investigator Site | |
Veldhoven, Netherlands | |
Novartis Investigator site | |
Eindhoven, Netherlands | |
Novartis investigator site | |
Heerlen, Netherlands | |
Novartis Investigator Site | |
Nijmegen, Netherlands | |
Novartis Investigator Site | |
Breda, Netherlands |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External affairs ) |
Study ID Numbers: | CQVA149A2204 |
Study First Received: | December 10, 2007 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00570778 |
Health Authority: | United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: Medicines Evaluation Board (MEB); Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada |
QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1 |
Lung Diseases, Obstructive Respiratory Tract Diseases Glycopyrrolate |
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |