Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Pasireotide; octreotide LAR 30mg; lanreotide ATG 120mg
Intervention description: 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; 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; 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
Intervention MeSH terms: Octreotide; Lanreotide; Pasireotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acromegaly; hormone disorder; growth hormone; insulin like growth factor-1; pituitary tumor; pasireotide; SOM230

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with written informed consent prior to any study related activity

          2. 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)

          3. 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

          4. Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have
             been previously submitted to surgery

          5. 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

        Exclusion Criteria:

          1. Patients who had received pasireotide (SOM 230) prior to enrolment

          2. 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.

          3. Patients who had compression of the optic chiasm causing acute clinically significant
             visual field defects

          4. Patients who required a surgical intervention for relief of any sign or symptom
             associated with tumor compression

          5. Patients who had received pituitary irradiation within 10 years prior to visit 1
             (screening).

          6. Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks
             prior to visit 1 (screening).

          7. Patients who were hypothyroid and not adequately treated with a stable dose of thyroid
             hormone replacement therapy