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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
Show 21 Study Locations| 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 |
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COPD, Glycopyrrolate, antimuscarinic |
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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 |