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NCT02305797 · ClinicalTrials.gov registry record · Phase 3
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
A Phase 3 study of Generalized Anxiety Disorder (GAD), sponsored by Edgemont Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 495
- Enrollment target
- 1
- Study location
NCT02305797: Completed Phase 3 study of Generalized Anxiety Disorder (GAD), sponsored by Edgemont Pharmaceuticals.
NCT02305797 is a Phase 3 study of Generalized Anxiety Disorder (GAD) that has completed, run by Edgemont Pharmaceuticals. The registered enrollment target is 495 participants, above the 136-participant average among 6 other Generalized Anxiety Disorder (GAD) trials with a reported enrollment target (264% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02305797, a Phase 3 study of Generalized Anxiety Disorder (GAD), has completed, sponsored by Edgemont Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 495 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.
Primary Outcome
HAM-A Total Score was rated by the clinician. Scores range from 0 to 56. A lower score is favorable. Baseline was defined as the last non-missing value prior to receiving double-blind study drug.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Extended-release lorazepam
Study Locations (1)
California
- Multiple Investigational Sites - Multiple Locations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 495 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
What the finished NCT02305797 record still lists
NCT02305797 is an interventional study that assigns participants to a tested intervention. The registered 495 participants enrollment target is mid-sized for trials with a published cap, above the 136-participant average among 6 other Generalized Anxiety Disorder (GAD) trials with a reported enrollment target (264% higher).
The record links to 1 condition, with Generalized Anxiety Disorder (GAD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02305797 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02305797 about?
NCT02305797 is a clinical study titled "EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)". To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a stati...
What is the current status of trial NCT02305797?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2015-01. Estimated completion is 2016-05.
What conditions does trial NCT02305797 study?
This clinical trial studies the following conditions: Generalized Anxiety Disorder (GAD).
What interventions are being tested in trial NCT02305797?
The interventions under investigation include: Placebo (DRUG), Extended-release lorazepam (DRUG).
Who is sponsoring clinical trial NCT02305797?
This trial is sponsored by Edgemont Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02305797 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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