A Multicenter, Open-label, Randomized, Phase II Study to Evaluate Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Pasireotide LAR in Japanese Patients With Active Acromegaly or Pituitary Gigantism
18 Years
N/A
Both
Acromegaly, Pituitary Gigantism
Trial Information
A Multicenter, Open-label, Randomized, Phase II Study to Evaluate Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Pasireotide LAR in Japanese Patients With Active Acromegaly or Pituitary Gigantism
Inclusion Criteria:
- Patients with medication naïve acromegaly or pituitary gigantism
- Patients with inadequately controlled acromegaly or pituitary gigantism
Exclusion Criteria:
- Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c >8%
- Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,
sustained ventricular tachycardia, ventricular fibrillation, clinically significant
bradycardia, advanced heart block or a history of acute myocardial infarction within
the six months preceding enrollment
- Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF
> 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT
syndrome, or patients receiving a concomitant medication known to prolong QT interval
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Growth Hormone (GH) and glucagon-like peptide-1 (IGF-1)
Outcome Description:
Assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L and the normalization of IGF-1 at 3 months of study treatment.
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CSOM230C1202
NCT ID:
NCT01673646
Start Date:
October 2012
Completion Date:
February 2016
Related Keywords:
- Acromegaly, Pituitary Gigantism
- SOM230, Pasireotide, acromegaly, Phase II
- Acromegaly
- Gigantism
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