drugset / Trial / NCT01673646
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pasireotide | Other / unclassified | 20 mg | Intramuscular |
| Subject | Pasireotide | Other / unclassified | 40 mg | Intramuscular |
| Subject | Pasireotide | Other / unclassified | 60 mg | Intramuscular |