Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
This study has been completed.
Information provided by (Responsible Party):
First received: January 18, 2012
Last updated: November 10, 2014
Last verified: October 2014
To study the effect of midodrine against the symptoms of orthostatic hypotension
Symptomatic Orthostatic Hypotension
Drug: Midodrine HCl
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Percent of Subjects Who Failed to Maintain a Response [ Time Frame: 30 minutes post-dose on Day 16 ] [ Designated as safety issue: No ]
Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16:
- 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.
- 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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Experimental: Midodrine HCl
Drug: Midodrine HCl
dose at subject's current dose level
Other Name: ProAmatine®
Placebo Comparator: Placebo
single dose of matching placebo
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01515865
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 18, 2012
|Results First Received:
||October 16, 2014
||November 10, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Autonomic Nervous System Diseases
Nervous System Diseases
Adrenergic alpha-1 Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs