A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

CompletadoFase 3ClinicalTrials.gov

ID: NCT00600886Tipo: INTERVENTIONALInicio: 11 de feb de 2008Fin estimado: 11 de mar de 2016

Traducción no disponible, mostrando original

Resumen

The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study was 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. Following one year of treatment patients could proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients with active acromegaly (based on elevated GH and IGF-1 levels)
Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or 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

Criterios de exclusión

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

Intervenciones

drug

Pasireotide

Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.

drug

Octreotide

Octreotide LAR - i.m. depot injection given once every 28 days.

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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