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NCT02558829 · ClinicalTrials.gov registry record · Phase 3
Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
A Phase 3 study, sponsored by AEterna Zentaris.
- Completed
- Registry status
- Phase 3
- Development phase
- 157
- Enrollment target
NCT02558829: Completed Phase 3 study, sponsored by AEterna Zentaris.
NCT02558829 is a Phase 3 study that has completed, run by AEterna Zentaris. The registered enrollment target is 157 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02558829, a Phase 3 study, has completed, sponsored by AEterna Zentaris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 157 participants
- Enrollment target
Study Summary
The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy control subjects.
Primary Outcome
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
Interventions
- DRUG Insulin
- DRUG Macimorelin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2015-12-03 |
| Est. Completion | 2016-11-29 |
| Phase | Phase 3 |
What the finished NCT02558829 record still lists
NCT02558829 is an interventional study that assigns participants to a tested intervention. The registered 157 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Insulin is the first listed.
NCT02558829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02558829 about?
NCT02558829 is a clinical study titled "Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency". The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy control subjects.
What is the current status of trial NCT02558829?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 157 participants. The study started on 2015-12-03. Estimated completion is 2016-11-29.
What interventions are being tested in trial NCT02558829?
The interventions under investigation include: Insulin (DRUG), Macimorelin (DRUG).
Who is sponsoring clinical trial NCT02558829?
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 NCT02558829's enrollment target sits among peer trials
157 1505th of 2000 higher than 495 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
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