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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02558829 | Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency | PHASE3 | COMPLETED | 157 | — | — | Dec 3, 2015 | Nov 29, 2016 | Apr 10, 2018 | 27 | United States, Austria +7 |
In the primary efficacy analysis, the estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The probability for a "Negative Agreement" equals the sum of the probability of both tests being correct (negative test results for both tests for subjects with "true non-AGHD") and the probability of both tests being wrong (negative test results for both tests for subjects with "true AGHD"). The performance of the GHST with Macimorelin was considered to be acceptable if the lower bound of the two-sided 95% confidence interval (or lower bound of the one-sided 97.5% confidence interval) for the primary efficacy variables was 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'. The following cut-off values for stimulated GH levels were used: - MAC: GH: 2.8 ng/mL, - ITT: GH: 5.1 ng/mL.
| Arm | Type | Description |
|---|---|---|
| GHST Sequence A | EXPERIMENTAL | 1st Macimorelin-GHST, 2nd Insulin Tolerance Test |
| GHST Sequence B | EXPERIMENTAL | 1st Insulin Tolerance Test, 2nd Macimorelin-GHST |
| Name | Type | Description |
|---|---|---|
| Macimorelin | DRUG | macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose |
| Insulin | DRUG | Insulin, 0.10 U/kg (0.15 U/kg if BMI \> 30 kg/m2), intravenous injection, single dose |
Inclusion Criteria: * Suspected growth hormone deficiency (GHD), based on either of the following: * structural hypothalamic or pituitary disease, or * surgery or irradiation in these areas, or * head trauma as an adult, or * evidence of other pituitary hormone deficiencies, or * idiopat...