Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension
Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension
1 other identifier
interventional
90
1 country
1
Brief Summary
To evaluate the efficacy of a 4-week fludrocortisone (FLU) treatment on systolic blood pressure depression after 5 minutes of active orthostatism in patients with neurogenic orthostatic hypotension (HON) symptomatic, despite treatment with non-drug measures with or without midodrine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2020
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedStudy Start
First participant enrolled
July 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedOctober 2, 2023
September 1, 2023
3.9 years
October 14, 2019
September 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Systolic BP diminution
Systolic BP diminution when moving from supine to standing, measured with a semi-automatic blood pressure monitor \- AP in upright position: the lowest value of the measurements obtained every minute, for 5 minutes after rising.
8 weeks
Study Arms (2)
fludrocortisone
EXPERIMENTALFLUCORTAC® 50 μg (tablet breackable). One tablet during the first week. Then 2 tablets during the second week. Then 3 tablets during the third week and finally 4 tablets during the 4th week. Maximum of 200μg/day.
Placebo
PLACEBO COMPARATORplacebo of flucortac and same diagram of administration
Interventions
50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
Eligibility Criteria
You may qualify if:
- Diagnosis of orthostatic hypotension (HO), ie a blood pressure drop\> 20 and / or 10 mmHg within 3 minutes after active and symptomatic lifting
- Patient suffering from a neurological disease
- orthostatic neurogenic hypotension persistent and symptomatic despite non-drug measures
You may not qualify if:
- Hypersensitivity to FLU or any of its excipients
- non orthostatic neurogenic hypotension
- History of proven heart failure
- History of left ventricular systolic dysfunction
- Uncompensated hypokalemia
- Patient with poorly balanced Grade 3 hypertension
- Nursing patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H.A.C. PHARMAlead
Study Sites (1)
Hôpital Broca (AP-HP)
Paris, 75010, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Michel SENARD, MD
National Coordinator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 16, 2019
Study Start
July 9, 2020
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
October 2, 2023
Record last verified: 2023-09