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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00929110 |
Purpose
This study is designed to investigate 1 year efficacy and safety data for the 50µg o.d. dose of NVA237 in patients with moderate to severe chronic obstructive pulmonary disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: NVA237 Drug: Placebo to NVA Drug: Tiotropium |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment |
| Official Title: | A 52-week Treatment, Randomized, Double-blind, Placebo-controlled, With Open Label Tiotropium, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease. |
| Estimated Enrollment: | 1065 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| NVA237 50µg once daily: Experimental |
Drug: NVA237
50µg once daily
|
| Placebo to NVA: Placebo Comparator |
Drug: Placebo to NVA
once daily
|
| Tiotropium 18µg once daily: Active Comparator |
Drug: Tiotropium
18µg once daily
|
Eligibility| 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
Contacts and Locations| Contact: Novartis Pharmaceuticals | 862-778-8300 |
Show 139 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CNVA237A2303, EUDRACT 2008-008394-63 |
| Study First Received: | June 25, 2009 |
| Last Updated: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00929110 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; Chile: Comisión Nacional de Investigación Científica y Tecnológica; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Israel: Ministry of Health; Italy: The Italian Medicines Agency; Korea: Food and Drug Administration; Malaysia: Ministry of Health; Mexico: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); New Zealand: Food Safety Authority; Peru: Ministry of Health; Philippines: Bureau of Food and Drugs; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; South Africa: Department of Health; Thailand: Food and Drug Administration; Turkey: Ministry of Health; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
COPD, NVA237, glycopyrronium |
|
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Respiration Disorders Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |