Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly - NCT00600886-Sao Paulo


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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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City:

Sao Paulo

Country:

Brazil

Conditions:

Acromegaly

Purpose:

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.

Study summary:

Criteria:

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

Study is available at:

Sao Paulo
Brazil

Primary Contact:
Novartis U.S.
Phone: 1800-340-6843

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:

ClinicalTrials.gov

Date Processed:

November 4, 2009

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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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