An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171730
First received: September 13, 2005
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. This study will assess the long-term safety and efficacy of pasireotide in patients with acromegaly.


Condition Intervention Phase
Acromegaly
Drug: Pasireotide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Circulating GH- and IGF-1 concentrations measured every 4 weeks [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term safety and efficacy of multiple doses of Pasireotide s.c. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2004
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide s.c. (SOM230) Drug: Pasireotide

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have completed all four treatment regimens in the core study CSOM230B2201 and achieved biochemical control in GH and IGF-1 levels after at least one month of pasireotide administration at any of the three doses
  • Patients who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201

Exclusion Criteria:

  • Patients who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B2201
  • Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B2201 Patients who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study CSOM230B2201

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171730

Locations
United States, California
Cedars Sinai Medical Center Dept. of Pituitary Ctr.
Los Angeles, California, United States, 90048
United States, Michigan
University of Michigan Health System StudyCoordinatorCSOM230B2201E1
Ann Arbor, Michigan, United States, 48109
United States, New York
NYU / VA Medical Center
New York, New York, United States, 10010
Australia, Queensland
Novartis Investigative Site
Woolloongabba, Queensland, Australia, 4102
Belgium
Novartis Investigative Site
Edegem, Belgium, 2650
France
Novartis Investigative Site
Toulouse Cédex 4, France, 31043
Germany
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Muenchen, Germany, 80336
Italy
Novartis Investigative Site
Napoli, Italy, 80131
Switzerland
Novartis Investigative Site
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171730     History of Changes
Other Study ID Numbers: CSOM230B2201E1, 2004-002849-12
Study First Received: September 13, 2005
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Acromegaly
Pasireotide
GH
IGF-1

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014