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
Summary
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 MonthsThe Percentage of Participants With Partial Response (PR) at 8 Months
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
|