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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
40 mg intramuscular (i.m.) every 28 days for 3 months
Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months
Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows: 1. st week: 0.25 mg twice a week (0.50 mg/week) 2. nd week: 0.50 mg/week twice a week (1 mg/week) 3. rd week: 0.50 mg four times a week (2 mg/week) 4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)
Novartis Investigative Site
Brest, France
Novartis Investigative Site
Bron, France
The Percentage of Participants With Complete Response (CR) at 8 Months
A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment: * Mean 1 hour GH \< 2.5µg/L (according to Central Laboratory); and * IGF-I within the Central Laboratory Normal Range (for age and gender).
Time frame: From Baseline to 8 months
The Percentage of Participants With Complete Response (CR) At 3 Months
A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment: * Mean 1 hour GH \< 2.5µg/L (according to Central Laboratory); and * IGF-I within the Central Laboratory Normal Range (for age and gender)
Time frame: From Baseline to 3 months
The Percentage of Participants With Partial Response (PR) at 8 Months
Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment. * Mean 1 hour GH \> 2.5 µg/L and \< 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range. * Mean 1 hour GH \< 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range.
Time frame: From Baseline to 8 months
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Novartis Investigative Site
Le Kremlin-Bicêtre, France
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Nîmes, France
Novartis Investigative Site
Pessac, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Genova, Italy
Novarts Investigative Site
Naples, Italy
Novartis Investigative Site
Napoli, Italy
...and 10 more locations