Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Brief Title

Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Official Title

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

Brief 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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.

Secondary Outcome

 Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)

Condition

Acromegaly

Intervention

Pasireotide

Study Arms / Comparison Groups

 Pasireotide LAR 40 mg

Description:  Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

198

Start Date

July 19, 2010

Completion Date

February 28, 2017

Primary Completion Date

January 22, 2013

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

Argentina

Location Countries

Argentina

NCT ID

NCT01137682

Organization ID

CSOM230C2402

Secondary IDs

EUDRACT 2009-016722-13

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Verification Date

April 2018