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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00448747 | Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test. | PHASE3 | COMPLETED | 101 | — | — | Jun 1, 2007 | Jul 1, 2011 | Jul 23, 2019 | 13 | United States |
The primary endpoint for each individual is the peak GH concentration following AEZS-130 (macimorelin) administration.
| Arm | Type | Description |
|---|---|---|
| AEZS-130 ( formerly ARD-07) | EXPERIMENTAL | A single oral administration of AEZS-130 (0.5 mg/kg po) as Growth Hormone Stimulation Test |
| L-ARG+GHRH | ACTIVE_COMPARATOR | This trial was set up as a multi-center, randomized, cross-over study investigating AEZS-130 as a Growth Hormone Stimulation Tests in terms of safety and efficacy compared to L-ARG+GHRH. When GHRH became unavailable on the US market, this comparator arm was no longer available, which was addressed by Amendment No. 3 (version 27-March-2010). Control subject enrolled under Amendment No. 3 were not randomized as there was no cross-over due to unavailability of L-ARG+GHRH. These control subjects received only AEZS-130 |
| Name | Type | Description |
|---|---|---|
| AEZS-130 (formerly ARD-07) | DRUG | A single oral administration of AEZS-130 as Growth Hormone Stimulation Test |
| L-ARG+GHRH | DRUG | A single administration of L-ARG+GHRH (iv bolus) followed by a 30min infusion of L-ARG as Growth Hormone Stimulation Test |
Inclusion for Matched Control Subjects: * Undergone normal growth and development * Normal serum prolactin (PRL) concentrations * Females should have a history of regular, age-appropriate menses * Males should have normal serum testosterone concentrations * Matched GHD subject already enrolled in s...