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NCT01156415 · ClinicalTrials.gov registry record · Phase 3
Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 837
- Enrollment target
NCT01156415 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 837 participants.
The verdict
NCT01156415, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 837 participants
- Enrollment target
Study Summary
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase. Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study. Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
Interventions
- DRUG AGO178
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 837 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01156415
The ClinicalTrials.gov registry entry for NCT01156415 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 837 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AGO178 is the first listed.
NCT01156415 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01156415 about?
NCT01156415 is a clinical study titled "Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)". The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase. Cohort I is restricted to include patients who have completed a previous Novartis...
What is the current status of trial NCT01156415?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 837 participants. The study started on 2010-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01156415?
The interventions under investigation include: AGO178 (DRUG).
Who is sponsoring clinical trial NCT01156415?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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