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Fludrocortisone in neurogenic orthostatic hypotension
NCT04128137Phase 4
Key facts
- Status
- Recruiting
- Start
- Jul 2020
- Primary completion
- Jun 2024
- Countries
- 1
- Sponsor
- HAC Pharma
- Modality
- Orthosteric Ligands
- Drugs
- fludrocortisone
- Conditions
- Neurogenic Orthostatic Hypotension (nOH)
01
Overview
Phase 4, randomised, double-blind trial in Neurogenic Orthostatic Hypotension (nOH) comparing Fludrocortisone with Placebo (2 arms). Primary endpoint: Systolic Blood Pressure Diminution at 8 weeks. Started Jul 2020; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Fludrocortisone
Fludrocortisone titration to maintenance
Placebo
Placebo titration to maintenance
03
Who it enrols
Adult patients with persistent symptomatic neurogenic orthostatic hypotension despite non-drug measures, with a documented blood pressure drop >20/10 mmHg upon standing.
04
Endpoints
Primary
Systolic Blood Pressure Diminution
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