Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

October 16, 2012

Primary Completion Date

April 10, 2017

Study Completion Date

April 10, 2017

Conditions
AcromegalyPituitary Gigantism
Interventions
DRUG

Pasireotide LAR

Intramuscular administration of pasireotide LAR was repeated every month (1 month = 28 days) for 12 months in core phase. It was permitted to increase the dose up to 60 mg in a patient showing the following biochemical test results after 3 and 6 months of study treatment: mean GH levels ≥2.5 µg/L and/or IGF-1 \> ULN. In the event of any problem with tolerability, it was permitted to reduce the next lower dosage level at any time.

Trial Locations (27)

466 8560

Novartis Investigative Site, Nagoya

470 1192

Novartis Investigative Site, Toyoake

812-8582

Novartis Investigative Site, Fukuoka

807-8556

Novartis Investigative Site, Kitakyushu

960 1295

Novartis Investigative Site, Fukushima

060 8648

Novartis Investigative Site, Sapporo

650-0017

Novartis Investigative Site, Kobe

020 8505

Novartis Investigative Site, Morioka

890 8520

Novartis Investigative Site, Kagoshima

259-1193

Novartis Investigative Site, Isehara

211-8510

Novartis Investigative Site, Kawasaki

222-0036

Novartis Investigative Site, Yokohama

612-8555

Novartis Investigative Site, Kyoto

980 8574

Novartis Investigative Site, Sendai

700-8558

Novartis Investigative Site, Okayama

530-8480

Novartis Investigative Site, Osaka

565 0871

Novartis Investigative Site, Suita

359 8513

Novartis Investigative Site, Tokorozawa

420-8527

Novartis Investigative Site, Shizuoka

113 8655

Novartis Investigative Site, Bunkyo Ku

113-8603

Novartis Investigative Site, Bunkyo-ku

173-8610

Novartis Investigative Site, Itabashi-ku

105-8470

Novartis Investigative Site, Minato Ku

162 8666

Novartis Investigative Site, Shinjuku Ku

260 8677

Novartis Investigative Site, Chiba

534-0021

Novartis Investigative Site, Osaka

990 9585

Novartis Investigative Site, Yamagata

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY