A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

CompletadoFase 3ClinicalTrials.gov

ID: NCT01137682Tipo: INTERVENTIONALInicio: 19 de jul de 2010Fin estimado: 28 de feb de 2017

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients with written informed consent prior to any study related activity
Patients who had inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period \> 2.5 µg/L and sex- and age-adjusted IGF-1 \> 1.3 x upper limit of normal (ULN)
Patients who had been treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg
Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery
Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension

Criterios de exclusión

Patients who had received pasireotide (SOM 230) prior to enrolment
Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
Patients who had compression of the optic chiasm causing acute clinically significant visual field defects
Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening).
Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

Intervenciones

drug

Pasireotide

* Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or * Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks

drug

octreotide LAR 30mg

In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization

drug

lanreotide ATG 120mg

In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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