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NCT02586623 · ClinicalTrials.gov registry record · Phase 4
Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
A Phase 4 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 4
- Development phase
- 453
- Enrollment target
NCT02586623: Completed Phase 4 study, sponsored by H. Lundbeck A/S.
NCT02586623 is a Phase 4 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 453 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02586623, a Phase 4 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 453 participants
- Enrollment target
Study Summary
To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)
Primary Outcome
Kaplan-Meier estimates are presented for time to treatment intervention. The estimates represent the quartiles of the survival time, where 50% corresponds to the median time to need for treatment intervention. Need for intervention is defined as meeting ANY of the following criteria during the Double-Blind Treatment Period: * OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) AND lack of efficacy as judged by the investigator; OR * OHSA Item #1 ≥2 unit worsening from Randomization (Vi
Interventions
- DRUG Placebo capsules
- DRUG Droxidopa capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2016-02-11 |
| Est. Completion | 2022-09-09 |
| Phase | Phase 4 |
What the finished NCT02586623 record still lists
NCT02586623 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo capsules is the first listed.
NCT02586623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02586623 about?
NCT02586623 is a clinical study titled "Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension". To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for...
What is the current status of trial NCT02586623?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 453 participants. The study started on 2016-02-11. Estimated completion is 2022-09-09.
What interventions are being tested in trial NCT02586623?
The interventions under investigation include: Placebo capsules (DRUG), Droxidopa capsules (DRUG).
Who is sponsoring clinical trial NCT02586623?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02586623's enrollment target sits among peer trials
453 187th of 2000 higher than 1,814 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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