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

Novartis

Status and phase: Completed; Phase 2

Conditions: Pituitary Gigantism; Acromegaly

Treatments: Drug: Pasireotide LAR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01673646

CSOM230C1202

Details and patient eligibility

About

To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study treatment.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Pasireotide LAR 20mg

Experimental group

Description:

Enrolled patients were randomized to 20mg pasireotide LAR.

Treatment:

Drug: Pasireotide LAR

Pasireotide LAR 40mg

Experimental group

Description:

Enrolled patients were randomized to 40mg pasireotide LAR.

Treatment:

Drug: Pasireotide LAR

Pasireotide LAR 60mg

Experimental group

Description:

Enrolled patients were randomized to 60mg pasireotide LAR.

Treatment:

Drug: Pasireotide LAR