Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Pasireotide
  • Drug: Octreotide

Phase:

Phase 3

Eligibility


Inclusion criteria:

   - 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

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jacob Petralia
6507212830
Not Recruiting