Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01515865
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : October 22, 2014
Last Update Posted : November 21, 2014
Information provided by (Responsible Party):

Brief Summary:
To study the effect of midodrine against the symptoms of orthostatic hypotension

Condition or disease Intervention/treatment Phase
Symptomatic Orthostatic Hypotension Drug: Midodrine HCl Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Midodrine HCl Drug: Midodrine HCl
dose at subject's current dose level
Other Name: ProAmatine®
Placebo Comparator: Placebo Drug: Placebo
single dose of matching placebo

Primary Outcome Measures :
  1. Percent of Subjects Who Failed to Maintain a Response [ Time Frame: 30 minutes post-dose on Day 16 ]

    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01515865

  Hide Study Locations
United States, California
California Clinical Trials Medical Group
Glendale, California, United States, 91206
North Hollywood, California, United States, 91606
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Advance Research Institute Inc
New Port Richey, Florida, United States, 34653
DMI Reasearch Inc
Pinellas Park, Florida, United States, 33782
Parkinson's Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, United States, 33980
United States, Illinois
Chicago Medical VA
North Chicago, Illinois, United States, 60064
United States, Kansas
Analab Clinical Research Inc
Lenexa, Kansas, United States, 66219
United States, Maryland
PAREXEL International - Baltimore EPCU Harbor Hospital
Baltimore, Maryland, United States, 21225
United States, New Jersey
Frontage Clinical Services
Hackensack, New Jersey, United States, 07601
United States, New York
Buffalo Clinical Research Center (BCRC)
Buffalo, New York, United States, 14202
Columbia University
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Kidney and Hypertension Center
Roseburg, Oregon, United States, 97471
United States, Tennessee
New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
UT South West Medical Center
Dallas, Texas, United States, 75390
The Heartbeat Clinic, PA
McKinney, Texas, United States, 75069
United States, Utah
Aspen Clinical Research
Orem, Utah, United States, 84058
Czech Republic
Fakultní nemocnice Hradec Králové
Hradec, Králové, Czech Republic, 500 05
Fakultní nemocnice Ostrava
Ostrava, Poruba, Czech Republic, 708 52
Fakultní nemocnice v Motole
Praha, Czech Republic, 150 06
EMC Silesia Sp. z o.o.; NZOZ Szpital Geriatryczny im. Jana Pawła II w Katowicach
Katowice, Poland, 40-353
Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala, + satelite site:NZOZ Szpital Avimed Sp. z o.o.
Katowice, Poland, 40-588
Centrum Medyczne HCP, Lecznictwo Stacjonarne, Oddział Udarowy
Poznań, Poland, 61-485
MTZ Clinical Research Sp. z o.o.
Warszawa, Poland, 02-106
Wojskowy Instytut Medyczny, Klinika Neurologiczna
Warszawa, Poland, 04-141
Neurologická klinika SZU a UNB, Univerzitná nemocnica Bratislava
Bratislava, Slovakia, 826 06
Neurologická klinika UN Martin, Univerzitná nemocnica Martin
Martin, Slovakia, 036 59
Neurologická klinika FN Nitra, Fakultná nemocnica Nitra
Nitra, Slovakia, 949 01
Neurologické oddelenie, Nemocnica s poliklinikou Spišská Nová Ves, a.s.
Spišská Nová Ves, Slovakia, 052 01
Neurologické oddelenie FN Trnava, Fakultná nemocnica Trnava
Trnava, Slovakia, 917 75
Neurologické oddelenie FNsP Žilina, Fakultná nemocnica s poliklinikou Žilina
Žilina, Slovakia, 012 07
Sponsors and Collaborators

Responsible Party: Shire Identifier: NCT01515865     History of Changes
Other Study ID Numbers: SPD426-405
2012-005760-99 ( EudraCT Number )
First Posted: January 24, 2012    Key Record Dates
Results First Posted: October 22, 2014
Last Update Posted: November 21, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action