Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension
Primary Purpose
Neurogenic Orthostatic Hypotension
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Fludrocortisone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neurogenic Orthostatic Hypotension
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnant patient at the time of inclusion
- Nursing patient
Sites / Locations
- Hôpital Broca (AP-HP)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
fludrocortisone
Placebo
Arm Description
FLUCORTAC® 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 of flucortac and same diagram of administration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04128137
Brief Title
Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension
Official Title
Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H.A.C. PHARMA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The objective of the study is to demonstrate the efficacy of FLU on systolic blood pressure depression in patients with neurogenic orthostatic hypotension. The study is randomised versus placebo.Each patient will be followed for a maximum of 5 months, with no more than 8 visits to the investigator (V0 at Day-7, V1 at D0, V2 at D7, V3 at D+14, V4 at D+21, V5 at D+ 28, V6 at D+56 and V7 only for patients on the FLU arm at D+140.
The presence of a comparator control group with placebo permits to evaluate the efficacy and the tolerance of FLU independently of the natural evolution of the pathology, in patients benefiting from a non-drug or possibly medicated treatment (midodrine) but insufficient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Orthostatic Hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fludrocortisone
Arm Type
Experimental
Arm Description
FLUCORTAC® 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo of flucortac and same diagram of administration
Intervention Type
Drug
Intervention Name(s)
Fludrocortisone
Other Intervention Name(s)
Flucortac
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Systolic BP diminution
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Pregnant patient at the time of inclusion
Nursing patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine DENICOURT
Phone
02 31 47 92 46
Email
catherine.denicourt@hacpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel SENARD, MD
Organizational Affiliation
National Coordinator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Broca (AP-HP)
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier HANON, MD
Email
Olivier.hanon@aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension
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