Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
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| ClinicalTrials.gov Identifier: NCT01515865 |
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Recruitment Status :
Completed
First Posted : January 24, 2012
Results First Posted : October 22, 2014
Last Update Posted : June 9, 2021
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Sponsor:
Shire
Information provided by (Responsible Party):
Takeda ( Shire )
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 98 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 |
| Actual Study Start Date : | May 23, 2012 |
| Actual Primary Completion Date : | November 11, 2013 |
| Actual Study Completion Date : | November 11, 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Orthostatic hypotension
MedlinePlus related topics:
Low Blood Pressure
| 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 :
- 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, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
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 ClinicalTrials.gov identifier (NCT number): NCT01515865
Locations
Show 32 study locations
Sponsors and Collaborators
Shire
Investigators
| Study Director: | Study Director | Takeda |
| Responsible Party: | Shire |
| ClinicalTrials.gov Identifier: | NCT01515865 |
| 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: | June 9, 2021 |
| Last Verified: | May 2021 |
Additional relevant MeSH terms:
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Hypotension, Orthostatic Hypotension Vascular Diseases Cardiovascular Diseases Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Midodrine Sympathomimetics |
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 |