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Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acromegaly

Intervention: Sandostatin LAR (Drug); pegvisomant (Drug); cabergoline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals


This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.

Clinical Details

Official title: An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Percentage of Participants With Complete Response (CR) at 8 Months

Secondary outcome:

The Percentage of Participants With Complete Response (CR) At 3 Months

The Percentage of Participants With Partial Response (PR) at 8 Months


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: • Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2. 5 ng/mL and elevated IGF-1 (adjusted for age and gender)

- Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25%

from any medical pretreatment level

- Patient currently receiving somatostatin-analogues at conventional regimen (maximum

registered dose) for at least 6 months before inclusion Exclusion Criteria:

- Newly diagnosed or previously medically untreated acromegalic patient

- Concomitant treatment with GH-receptor antagonist

- Concomitant treatment with dopamine-agonist

- Symptomatic cholelithiasis or choledocolithiasis

- Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according

to local laboratory)

- Previous gamma-knife radiotherapy for treatment of acromegaly

- Compression of the optic chiasm causing visual field defect

- Any medical conditions contraindicated in the Summary of Product Characteristic (SPC)

of all drugs Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative Site, Brest Cedex 29609, France

Novartis Investigative Site, Bron Cedex 69677, France

Novartis Investigative Site, Kremlin-Bicetre 94275, France

Novartis Investigative Site, Nice 06202, France

Novartis Investigative Site, Nimes 30029, France

Novartis Investigative Site, Pessac 33604, France

Novartis Investigative Site, Toulouse 31059, France

Novartis Investigative Site, Genova 16132, Italy

Novarts Investigative Site, Naples, Italy

Novartis Investigative Site, Napoli 80131, Italy

Novartis Investigative Site, Padova, Italy

Novartis Investigative Site, Perugia 06126, Italy

Novartis Investigative Site, Pisa 56124, Italy

Novartis Investigative Site, Torino 10126, Italy

Novartis Investigative Site, Lodz 91-425, Poland

Novartis Investigative Site, Warszawa, Poland

Novartis Investigative Site, Wroclaw, Poland

Novartis Investigative Site, Zabrze 41-800, Poland

Novartis Investigative Site, Porto 4200-319, Portugal

Novartis Investigative Site, Lausanne CH-1011, Switzerland

Additional Information

Starting date: September 2006
Last updated: April 20, 2011

Page last updated: August 23, 2015

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