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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
H.A.C. PHARMA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Orthostatic Hypotension

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 14, 2019
Last Updated
September 29, 2023
Sponsor
H.A.C. PHARMA
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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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