Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly - NCT00600886-Sao Paulo - 0020 (Clinical Trial 199535)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy199535.aspx
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Sao Paulo |
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Country:
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Brazil |
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| Conditions: |
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Acromegaly |
| Purpose: |
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The patients will receive either Pasireotide LAR or Octreotide LAR for one year of
treatment.
The objective of this study is to compare the proportion of patients with a reduction of
mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and
sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12
months.
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| Study summary: |
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| Criteria: |
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Inclusion criteria:
- Male or female patients aged at least 18 years.
- Patients with active acromegaly.
- Patients who have undergone one or more pituitary surgeries, but have not been
treated medically.
- de-novo patients presenting a visible pituitary adenoma on MRI and who refuse
pituitary surgery or for whom pituitary surgery is contraindicated
- Patients for whom written informed consent to participate in the study has been
obtained prior to any study related activity.
Exclusion criteria:
- Patients who are being or were treated with octreotide, lanreotide, dopamine agonists
or GH antagonists with the exception of a single dose of short-acting octrotide or
short-acting dopamine agonists. In case of a single dose of short-acting octrotide,
the dose should not be used to predict the response to the octretide treatment. The
single dose of short-acting octreotide or short-acting dopamine agonists should not
be administered in the 3 days prior to randomization.
- Patients with compression of the optic chiasm causing any visual field defect.
- Patients who have received pituitary irradiation within the last ten years prior to
visit 1.
- Poorly controlled diabetic patients
Other protocol-defined inclusion/exclusion criteria may apply |
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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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November 4, 2009 |
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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