NCT01278342 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions

Acromegaly

Interventions

DRUG

Sandostatin LAR

40 mg intramuscular (i.m.) every 28 days for 3 months

DRUG

pegvisomant

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

DRUG

cabergoline

"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)"

Trial Locations (20)

10126

Novartis Investigative Site, Torino

16132

Novartis Investigative Site, Genova

29609

Novartis Investigative Site, Brest

30029

Novartis Investigative Site, Nîmes

31059

Novartis Investigative Site, Toulouse

33604

Novartis Investigative Site, Pessac

56124

Novartis Investigative Site, Pisa

69677

Novartis Investigative Site, Bron

80131

Novartis Investigative Site, Napoli

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

06202

Novartis Investigative Site, Nice

Unknown

Novarts Investigative Site, Naples

Novartis Investigative Site, Padua

Novartis Investigative Site, Warsaw

Novartis Investigative Site, Wroclaw

06126

Novartis Investigative Site, Perugia

91-425

Novartis Investigative Site, Lodz

41-800

Novartis Investigative Site, Zabrze

4200-319

Novartis Investigative Site, Porto

CH-1011

Novartis Investigative Site, Lausanne