drugset / Trial / NCT01673646

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

NCT01673646

Phase 2 Completed 33 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-10-16
Primary completion
2017-04-10
Completion
2017-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Pasireotide Other / unclassified 20 mg Intramuscular
Subject Pasireotide Other / unclassified 40 mg Intramuscular
Subject Pasireotide Other / unclassified 60 mg Intramuscular