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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00510510 |
Purpose
This study will assess the safety/tolerability of 28 days of treatment with NVA237 100 and 200µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: Glycopyrrolate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center Study, to Assess the Safety and Tolerability of 28 Days Treatment With NVA237 (100 or 200µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
| Estimated Enrollment: | 240 |
| Study Start Date: | August 2007 |
| Study Completion Date: | January 2008 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or during the screening period (up to visit 3).
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Pulmonary Associates | |
| Phoenix, Arizona, United States, 85006 | |
| Pulmonary Associates, | |
| Glendale, Arizona, United States, 85306 | |
| United States, Colorado | |
| Rocky Mountain Center for Clinical Research | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Delaware | |
| Lung Health & Sleep Enhancement Center | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Elite Research Institute | |
| Miami, Florida, United States, 33169 | |
| South Miami Clinical Research | |
| Miami, Florida, United States, 33143 | |
| Central Medical Group | |
| Tamarac, Florida, United States, 33321 | |
| United States, Illinois | |
| Asthma and Allergy Center of Chicago | |
| River Forest, Illinois, United States, 60305 | |
| United States, Kansas | |
| College Park Family Care Center. | |
| Overland Park, Kansas, United States, 66210-2761 | |
| United States, Missouri | |
| Midwest Chest Consultants. | |
| St. Chares, Missouri, United States, 63301 | |
| United States, North Carolina | |
| American Health Research | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Oregon | |
| Allergy Associates Research Center | |
| Portland, Oregon, United States, 97213 | |
| United States, South Carolina | |
| S Carolina Pharmaceutical Research | |
| Spartanburg, South Carolina, United States, 29303 | |
| Union Pharmaceutical Research | |
| Union, South Carolina, United States, 29379 | |
| United States, Texas | |
| F. Adam Kawley MD | |
| Houston, Texas, United States, 77024 | |
| Texas Pulmonary & Critical Care Consultants | |
| Ft Worth, Texas, United States, 76104 | |
| France | |
| Novartis | |
| Rueil-Malmaison, France | |
| Germany | |
| Novartis | |
| Nurnberg, Germany | |
| Netherlands | |
| Netherlands | |
| Arnhem, Netherlands | |
| Spain | |
| Novartis | |
| Barcelona, Spain | |
| Turkey | |
| Novartis | |
| Istanbul, Turkey | |
| Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | novartis ( external affairs ) |
| Study ID Numbers: | CNVA237A2206 |
| Study First Received: | August 1, 2007 |
| Last Updated: | January 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00510510 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Spain: Spanish Agency of Medicines; Turkey: Ministry of Health |
|
COPD, Glycopyrrolate, antimuscarinic |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Respiration Disorders Cholinergic Agents Pharmacologic Actions Adjuvants, Anesthesia |
Muscarinic Antagonists Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Glycopyrrolate Therapeutic Uses Central Nervous System Agents Pulmonary Disease, Chronic Obstructive |