1-year Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Chronic Obstructive Pulmonary Disease (COPD) - NCT00929110-34471 (Clinical Trial 299968)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy299968.aspx
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| City: |
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Ocala |
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State:
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FL |
| Zip Code: |
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34471 |
| Conditions: |
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Chronic Obstructive Pulmonary Disease |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior
to initiation of any study-related procedure.
2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the
Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
3. Current or ex-smokers who have a smoking history of at least 10 pack years.
4. Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and
post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (day -14)
5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3
(day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to
Visit 3.
Exclusion Criteria:
1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy
test).
2. Women of child-bearing potential, unless using an approved method of medical or
surgical contraception.
3. Patients requiring long term oxygen therapy (> 15 h a day) 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 between Visit 1 (day -21) and Visit 3
(day 1).
4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
(day -21).
5. Patients who, in the judgment of the investigator or the responsible Novartis
personnel, have a clinically relevant laboratory abnormality or a clinically
significant condition.
6. Patients with any history of asthma indicated by (but not limited to) a blood
eosinophil count > 600/mm3 (at visit 1) and onset of symptoms prior to age 40 years.
7. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (day
-21) (Fridericia method) is prolonged (>450 ms for males or > 470 ms for females
Other protocol-defined inclusion/exclusion criteria may apply |
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| Study is available at: |
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Novartis Investigative Site
Ocala, FL 34471
United States
Primary Contact:
Novartis Pharmaceuticals
Phone: 862-778-8300 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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