Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02354508 | Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues | PHASE3 | COMPLETED | 123 | — | — | Mar 31, 2015 | Sep 27, 2018 | Dec 10, 2019 | 50 | Argentina, Belgium +13 |
| NCT01673646 | Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism | PHASE2 | COMPLETED | 33 | — | — | Oct 16, 2012 | Apr 10, 2017 | Sep 16, 2019 | 27 | Japan |
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, overall by baseline diabetic status.
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)
Percentage of participants with a reduction of mean growth hormone (GH) levels to \< 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits (age and sex related) at 3 months across all doses
| Arm | Type | Description |
|---|---|---|
| Pasireotide LAR | EXPERIMENTAL | Patients who qualify for the core phase of the study will be treated with pasireotide LAR 40 mg initially. Patients not achieving biochemical control can be up-titrated to pasireotide LAR 60 mg. |
| Pasireotide LAR 20mg | EXPERIMENTAL | Enrolled patients were randomized to 20mg pasireotide LAR. |
| Pasireotide LAR 40mg | EXPERIMENTAL | Enrolled patients were randomized to 40mg pasireotide LAR. |
| Pasireotide LAR 60mg | EXPERIMENTAL | Enrolled patients were randomized to 60mg pasireotide LAR. |
| Name | Type | Description |
|---|---|---|
| Pasireotide LAR | DRUG | Pasireotide 40 mg and 60 mg. Pasireotide 20 mg which was allowed for dose decrease in case of adverse event. |
Inclusion Criteria: * Written informed consent * Male and female patients ≥18 years * Patients with confirmed diagnosis of inadequately controlled acromegaly (mean GH concentration ≥1 μg/L and sex- and age-adjusted IGF-1 \>1.3 x ULN) * Patients treated with octreotide LAR (30 mg or 40 mg) or lanreo...