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NCT01515865 · ClinicalTrials.gov registry record · Phase 4
Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 98
- Enrollment target
NCT01515865: Completed Phase 4 study, sponsored by Shire.
NCT01515865 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 98 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01515865, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 98 participants
- Enrollment target
Study Summary
To study the effect of midodrine against the symptoms of orthostatic hypotension
Primary Outcome
Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16: 1. The Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 score increased by \>=4 points compared to baseline. OHSA Item 1 is a dizziness scale that is scored on a range from 0 (no dizziness) to 10 (severe dizziness). A lower score indicates less severe symptoms. 2. There was an increase in the number of syncopal/near syncopal events or severity of events within 1
Interventions
- DRUG Placebo
- DRUG Midodrine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2012-05-23 |
| Est. Completion | 2013-11-11 |
| Phase | Phase 4 |
What the finished NCT01515865 record still lists
NCT01515865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01515865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01515865 about?
NCT01515865 is a clinical study titled "Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension". To study the effect of midodrine against the symptoms of orthostatic hypotension
What is the current status of trial NCT01515865?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 98 participants. The study started on 2012-05-23. Estimated completion is 2013-11-11.
What interventions are being tested in trial NCT01515865?
The interventions under investigation include: Placebo (DRUG), Midodrine HCl (DRUG).
Who is sponsoring clinical trial NCT01515865?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01515865's enrollment target sits among peer trials
98 854th of 2000 higher than 1,140 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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