Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00448747 · ClinicalTrials.gov registry record · Phase 3
Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
A Phase 3 study, sponsored by AEterna Zentaris.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT00448747: Completed Phase 3 study, sponsored by AEterna Zentaris.
NCT00448747 is a Phase 3 study that has completed, run by AEterna Zentaris. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00448747, a Phase 3 study, has completed, sponsored by AEterna Zentaris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
The diagnosis of growth hormone deficiency (GHD) in adults is established by laboratory testing in patients with an appropriate clinical history of hypothalamic pituitary disease. Two tests that are considered to be gold standard tests for the diagnosis of GHD are the insulin tolerance test (ITT) and growth hormone releasing hormone (GHRH) combined with L-arginine (L-ARG). However, these tests are either bothersome (given intravenously) to the patient or are linked with side effects. Therefore, an orally available compound like AEZS-130 (formerly ARD-07), if demonstrated to be safe and providing adequate sensitivity and specificity could be a welcome alternative and/or complement to the current available tests. The intent was to recruit 40 adult GHD (AGHD) patients and 40 healthy control subjects into this trial, but the original sponsor (Ardana Biosciences Ltd.) discontinued the study for financial reasons before this was completed. At the time of withdrawal of GHRH from the market in 2008, 42 AGHD patients and 10 normal controls had completed the study at 9 US sites. This study reactivated to complete the remaining 30 matched control subjects. Additionally upon agreement with the FDA in a Special Protocol Assessment (SPA), 10 additional adult growth hormone deficient and their matched control were planned to be enrolled into this trial for a total treated population of approximatively 100 subjects.
Primary Outcome
The primary endpoint for each individual is the peak GH concentration following AEZS-130 (macimorelin) administration.
Interventions
- DRUG AEZS-130 (formerly ARD-07)
- DRUG L-ARG+GHRH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2007-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00448747 record still lists
NCT00448747 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which AEZS-130 (formerly ARD-07) is the first listed.
NCT00448747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00448747 about?
NCT00448747 is a clinical study titled "Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.". The diagnosis of growth hormone deficiency (GHD) in adults is established by laboratory testing in patients with an appropriate clinical history of hypothalamic pituitary disease. Two tests that are considered to be gold standard tests for the diagnosis of GHD are the insulin tolerance test (ITT) an...
What is the current status of trial NCT00448747?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2007-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00448747?
The interventions under investigation include: AEZS-130 (formerly ARD-07) (DRUG), L-ARG+GHRH (DRUG).
Who is sponsoring clinical trial NCT00448747?
This trial is sponsored by AEterna Zentaris, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00448747's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04033497 · 101 participants · NA
Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases
- NCT05111574 · 101 participants · Phase 2
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
- NCT05984680 · 101 participants
COPD Care Pathway Among Patients With Cancer
- NCT06266299 · 101 participants · Phase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia