Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

Phase 4

Completed

• Conditions: Symptomatic Orthostatic Hypotension
• Interventions: Drug: Placebo; Drug: Midodrine HCl

• Registration Number: NCT01515865
• Lead Sponsor: Shire

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.

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-24
• Study Start: 2012-05-23
• Primary Completion: 2013-11-11
• Study Completion: 2013-11-11
• Results First Submitted: 2014-10-16
• Results First Submitted QC: 2014-10-16
• Results First Posted: 2014-10-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Midodrine HCl	Midodrine HCl	-

Primary Outcome Measures

Name	Time	Method
Percent of Subjects Who Failed to Maintain a Response	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.

Trial Locations

Locations (32)

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States

Pharmaseek-Burbank; 🇺🇸 North Hollywood, California, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

Advance Research Institute Inc; 🇺🇸 New Port Richey, Florida, United States

DMI Reasearch Inc; 🇺🇸 Pinellas Park, Florida, United States

Parkinson's Disease Treatment Center of Southwest Florida; 🇺🇸 Port Charlotte, Florida, United States

Chicago Medical VA; 🇺🇸 North Chicago, Illinois, United States

Analab Clinical Research Inc; 🇺🇸 Lenexa, Kansas, United States

PAREXEL International - Baltimore EPCU Harbor Hospital; 🇺🇸 Baltimore, Maryland, United States

Frontage Clinical Services; 🇺🇸 Hackensack, New Jersey, United States

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