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Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

Primary Purpose

Symptomatic Orthostatic Hypotension

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Midodrine HCl
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Orthostatic Hypotension

Eligibility Criteria

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

Inclusion Criteria:

  1. Male and female subjects must be 18 years of age or older and ambulatory.
  2. Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test.
  3. A documented history of severe Symptomatic Orthostatic Hypotension (SOH) that, in the judgment of the treating physician, has required treatment with midodrine HCl, and has been at a stable dose for at least 3 months.
  4. The subject has manifested at least 1 of the following symptoms while standing or had a medical history of 1 of the following when not treated for orthostatic hypotension (OH): dizziness, lightheadedness, feeling faint, or feeling like they might black out.

Exclusion criteria

  1. The subject is a pregnant or lactating female.
  2. The subject has pre-existing sustained supine hypertension greater than 180mmHg systolic and 110mmHg diastolic BP or had these measurements at the Screening Visit. Sustained is defined as persistently greater at 2 separate measurements at least 5 minutes apart with the subject supine and at rest for the 5 minutes.
  3. Subjects taking concomitant medications of interest are excluded unless those medications are reviewed and discussed with the Medical Monitor or Study Physician and documented prior to enrolling the subject. If agreement is reached between the Investigator and Sponsor for the subject to continue in the study, all allowed medications should be maintained at a constant dose throughout the study.
  4. The Principal Investigator deems any clinical laboratory test (at the Screening Visit) abnormality to be clinically significant
  5. The subject has participated in other studies of investigational drugs or devices within 30 days prior to enrollment in this study (other than Study SPD426-406).
  6. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
  7. The subject has a concurrent chronic or acute illness, disability, or other condition (including significant unexpected laboratory or electrocardiogram [ECG] findings) that might confound the results of the tests and/or measurements administered in this study, or that might have increased the risk to the subject.
  8. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.
  9. Prior enrollment failure or randomization in this study.
  10. History of alcohol abuse or other substance abuse within the last year.

Sites / Locations

  • California Clinical Trials Medical Group
  • Pharmaseek-Burbank
  • Parkinson's Disease and Movement Disorders Center of Boca Raton
  • Advance Research Institute Inc
  • DMI Reasearch Inc
  • Parkinson's Disease Treatment Center of Southwest Florida
  • Chicago Medical VA
  • Analab Clinical Research Inc
  • PAREXEL International - Baltimore EPCU Harbor Hospital
  • Frontage Clinical Services
  • Buffalo Clinical Research Center (BCRC)
  • Columbia University
  • Cleveland Clinic
  • Kidney and Hypertension Center
  • New Orleans Center for Clinical Research - Knoxville
  • UT South West Medical Center
  • The Heartbeat Clinic, PA
  • Aspen Clinical Research
  • Fakultní nemocnice Hradec Králové
  • Fakultní nemocnice Ostrava
  • Fakultní nemocnice v Motole
  • EMC Silesia Sp. z o.o.; NZOZ Szpital Geriatryczny im. Jana Pawła II w Katowicach
  • Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala, + satelite site:NZOZ Szpital Avimed Sp. z o.o.
  • Centrum Medyczne HCP, Lecznictwo Stacjonarne, Oddział Udarowy
  • MTZ Clinical Research Sp. z o.o.
  • Wojskowy Instytut Medyczny, Klinika Neurologiczna
  • Neurologická klinika SZU a UNB, Univerzitná nemocnica Bratislava
  • Neurologická klinika UN Martin, Univerzitná nemocnica Martin
  • Neurologická klinika FN Nitra, Fakultná nemocnica Nitra
  • Neurologické oddelenie, Nemocnica s poliklinikou Spišská Nová Ves, a.s.
  • Neurologické oddelenie FN Trnava, Fakultná nemocnica Trnava
  • Neurologické oddelenie FNsP Žilina, Fakultná nemocnica s poliklinikou Žilina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Midodrine HCl

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent of Subjects Who Failed to Maintain a Response
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 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2012
Last Updated
May 25, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01515865
Brief Title
Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
Official Title
A Phase 4, Randomized-withdrawal, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects With Symptomatic Orthostatic Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2012 (Actual)
Primary Completion Date
November 11, 2013 (Actual)
Study Completion Date
November 11, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To study the effect of midodrine against the symptoms of orthostatic hypotension
Detailed Description
The efficacy of midodrine will be assessed in those subjects who have severe symptoms of orthostatic hypotension when not taking midodrine and are controlled when taking midodrine. The study will involve approximately 9 overnight stays.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Orthostatic Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midodrine HCl
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Midodrine HCl
Other Intervention Name(s)
ProAmatine®
Intervention Description
dose at subject's current dose level
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single dose of matching placebo
Primary Outcome Measure Information:
Title
Percent of Subjects Who Failed to Maintain a Response
Description
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 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness.
Time Frame
30 minutes post-dose on Day 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects must be 18 years of age or older and ambulatory. Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test. A documented history of severe Symptomatic Orthostatic Hypotension (SOH) that, in the judgment of the treating physician, has required treatment with midodrine HCl, and has been at a stable dose for at least 3 months. The subject has manifested at least 1 of the following symptoms while standing or had a medical history of 1 of the following when not treated for orthostatic hypotension (OH): dizziness, lightheadedness, feeling faint, or feeling like they might black out. Exclusion criteria The subject is a pregnant or lactating female. The subject has pre-existing sustained supine hypertension greater than 180mmHg systolic and 110mmHg diastolic BP or had these measurements at the Screening Visit. Sustained is defined as persistently greater at 2 separate measurements at least 5 minutes apart with the subject supine and at rest for the 5 minutes. Subjects taking concomitant medications of interest are excluded unless those medications are reviewed and discussed with the Medical Monitor or Study Physician and documented prior to enrolling the subject. If agreement is reached between the Investigator and Sponsor for the subject to continue in the study, all allowed medications should be maintained at a constant dose throughout the study. The Principal Investigator deems any clinical laboratory test (at the Screening Visit) abnormality to be clinically significant The subject has participated in other studies of investigational drugs or devices within 30 days prior to enrollment in this study (other than Study SPD426-406). Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures. The subject has a concurrent chronic or acute illness, disability, or other condition (including significant unexpected laboratory or electrocardiogram [ECG] findings) that might confound the results of the tests and/or measurements administered in this study, or that might have increased the risk to the subject. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients. Prior enrollment failure or randomization in this study. History of alcohol abuse or other substance abuse within the last year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
California Clinical Trials Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pharmaseek-Burbank
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Advance Research Institute Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
DMI Reasearch Inc
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Parkinson's Disease Treatment Center of Southwest Florida
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Chicago Medical VA
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Analab Clinical Research Inc
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
PAREXEL International - Baltimore EPCU Harbor Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Frontage Clinical Services
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Buffalo Clinical Research Center (BCRC)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kidney and Hypertension Center
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97471
Country
United States
Facility Name
New Orleans Center for Clinical Research - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
UT South West Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The Heartbeat Clinic, PA
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Fakultní nemocnice Hradec Králové
City
Hradec
State/Province
Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultní nemocnice Ostrava
City
Ostrava
State/Province
Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultní nemocnice v Motole
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
EMC Silesia Sp. z o.o.; NZOZ Szpital Geriatryczny im. Jana Pawła II w Katowicach
City
Katowice
ZIP/Postal Code
40-353
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala, + satelite site:NZOZ Szpital Avimed Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-588
Country
Poland
Facility Name
Centrum Medyczne HCP, Lecznictwo Stacjonarne, Oddział Udarowy
City
Poznań
ZIP/Postal Code
61-485
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Wojskowy Instytut Medyczny, Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Neurologická klinika SZU a UNB, Univerzitná nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Neurologická klinika UN Martin, Univerzitná nemocnica Martin
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Neurologická klinika FN Nitra, Fakultná nemocnica Nitra
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Neurologické oddelenie, Nemocnica s poliklinikou Spišská Nová Ves, a.s.
City
Spišská Nová Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
Neurologické oddelenie FN Trnava, Fakultná nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
Neurologické oddelenie FNsP Žilina, Fakultná nemocnica s poliklinikou Žilina
City
Žilina
ZIP/Postal Code
012 07
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

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