A Two Part Trial Investigating an Anti-obesity Drug ('2-0453) in Overweight/Obese Male and Female Healthy Volunteers - NCT01044108-47710 (Clinical Trial 464255)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy464255.aspx
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| City: |
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Evansville |
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State:
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IN |
| Zip Code: |
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47710 |
| Conditions: |
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Healthy - Obesity |
| Purpose: |
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This trial is conducted in the United States of America (USA). The aim of this trial is to
investigate the safety, tolerability, efficacy and pharmacokinetics (exposure of drug) of
'2-0453 in overweight/obese, but otherwise healthy male and female volunteers.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- FOR TRIAL PART 1, THE FOLLOWING APPLIES:
- Informed consent must be obtained before any trial-related activities. Trial-related
activities are any procedures that would not have been performed during the normal
management of the subject
- Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2
- Good general health
- FOR TRIAL PART 2, THE FOLLOWING APPLIES:
- Informed consent must be obtained before any trial-related activities. Trial-related
activities are any procedures that would not have been performed during the normal
management of the subject.
- Obese male and female subjects: Body Mass Index (BMI) between 30.0 to 39.0 kg/m2
- Good general health.
Exclusion Criteria:
- Aggressive diet attempts within the last 3 months
- Current or history of treatment with medications that may cause significant weight
gain
- History of major depressive disorder or history of a suicide attempt or history of
any suicidal behaviour
- History of eating disorders
- Any weight change of 5 kg (11 pounds) in the last 3 months
- Tobacco use
- History of alcoholism or drug/chemical abuse |
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| Study is available at: |
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Novo Nordisk Clinical Trial Call Center Evansville, IN 47710 United States
Primary Contact: Novo Nordisk Clinical Trial Call Center Phone: 866-867-7178 |
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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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February 17, 2010 |
Modifications to
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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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