Symptomatic orthostatic hypotension (SOH) MedDRA version: 15.1 Level: LLT Classification code 10021102 Term: Hypotension orthostatic symptomatic System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Midodrine Hydrochloride
Product Name: Midodrine
Product Code: SPD426
Pharmaceutical Form: Capsule
INN or Proposed INN: MIDOD
Sponsors
Shire Development LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects must be 18 years of age or older and ambulatory (when receiving adequate therapy for their SOH). 2. Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test. These females should abstain from sexual activity that could result in a pregnancy, or agree to use acceptable contraceptives throughout the period of the entire study and for 30 days after the last dose of investigational product. 3. A documented history of severe SOH (eg, due to Parkinson’s disease, Shy-Drager syndrome, multiple system atrophy, pure autonomic failure, or autonomic neuropathies) 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. 5. The subject is willing and able to undergo the procedures required by the protocol, including inpatient stay as required, assessment completion, protocol compliance, and participation in the placebo dosing period(s). 6. The subject has adequate hydration status (as assessed by physical examination and clinical laboratory parameters, eg, urine specific gravity). 7. Ability to provide written, signed, and dated informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
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 (screening test) abnormality 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 SPD426-405). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical benefit of midodrine HCl in subjects with SOH in a crossover design study by measuring the time to onset of syncopal symptoms/near syncope (of sufficient severity that would cause the subject to ask that the tilt table be returned to the horizontal position) during a protocolized tilt table test;Secondary Objective: To assess the safety of midodrine HCl after single dose administration;Primary end point(s): The primary endpoint in this study is the time (seconds) to onset of syncopal symptoms/near syncope as recorded in the tilt table tests performed at 1-hour post-dose on Days 2 and 3.; Timepoint(s) of evaluation of this end point: Day 2 and Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety will be assessed by adverse events (AEs), clinical laboratory parameters, vital signs (systolic and diastolic BP, pulse, body temperature, and respiratory rate), and electrocardiograms (ECGs).; Timepoint(s) of evaluation of this end point: From screening to the follow-up phone call. | — |
Countries
Czech Republic, Poland, Slovakia, United States
Contacts
Public ContactMedical Communications
Shire Pharmaceuticals Limited
Outcome results
None listed