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Phase 4 N=24 Randomized Quadruple-blind Treatment

Study to Assess the Benefit of Midodrine in the Treatment of Patients With Neurogenic Orthostatic Hypotension

Hypotension, Orthostatic

Enrolled (actual)
24
Serious AEs
4.2%
Results posted
May 2015
Primary outcome: Primary: Time to Onset of Near-syncopal Symptoms During Tilt Table Testing — 551.3; 461.0 seconds — p=0.1460

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Midodrine hydrochloride (Drug); Placebo (Drug)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
Shire
Primary completion
Mar 2005

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Onset of Near-syncopal Symptoms During Tilt Table Testing
551.3; 461.0 0.1460
PRIMARY
Time to Onset of Near-syncopal Symptoms During Tilt Table Testing Analysis #2
552.4; 460.0 0.0296 sig
PRIMARY
Time to Onset of Near-syncopal Symptoms During Tilt Table Testing-Re-analysis With The Koch Procedure
551.3; 461.0 0.0342 sig
SECONDARY
Time to Onset of Near-syncopal Symptoms in The Per-protocol Population
544.3; 447.9 0.2266
SECONDARY
Time to Onset of Near-syncopal Symptoms in The Per-protocol Population Analysis #2
545.1; 447.2 0.0418 sig
SECONDARY
Time to Near-syncopal Symptoms at Treatment Visit 1
539.5; 448.4 0.1928
SECONDARY
Duration of The Effect of Treatment at 3 Hours Post-dose
45.1; 48.0 0.9479
SECONDARY
Total Score of the Orthostatic Hypotension Symptom Assessment (OHSA)
13.7; 19.4 0.0590
SECONDARY
Scores for 6 Items of The OHSA
3.4; 4.7; 1.5; 2.7; 3.0; 4.1 0.0633
SECONDARY
Number of Participants With Improvement of Clinician Clinician's Global Impression- Improvement (CGI-I) Scores After Tilt Table Test
4; 4; 6; 4; 3; 5
SECONDARY
Number of Participants With Improvement of Patient CGI-I Scores After Tilt Table Test
3; 2; 5; 3; 3; 3
SECONDARY
Final Blood Pressure During Tilt Table Testing
106.5; 90.2; 70.6; 60.6 0.0378 sig
SECONDARY
Systolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2
142.2; 97.3; 110.1; 94.9; 121.7; 102.9
SECONDARY
Diastolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2
81.5; 60.8; 79.6; 64.9; 66.1; 60.3
SECONDARY
Heart Rate at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2
77.6; 80.5; 77.7; 79.5; 79.7; 80.9
SECONDARY
Number of Participants With Shifts in Reference to Normal Range For Hematology Analytes at Discharge
1; 0; 0; 0; 0; 2
SECONDARY
Number of Participants With Shifts in Reference to Normal Range For Clinical Chemistry at Discharge
0; 2; 1; 0; 1; 0
SECONDARY
Number of Participants With Shifts in Reference to Normal Range For Urinalysis at Discharge
1; 2; 0; 0; 0; 2

Summary

The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.

Eligibility Criteria

Inclusion Criteria

  • The male or female subjects must be 18 years of age or older and ambulatory. (Subjects must not require assistance with a walker or wheelchair to perform regular daily activities at all times.)
  • Women of childbearing potential must have a negative serum beta HCG pregnancy test at screening and baseline.
  • The subject has been diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathy (i.e. neurogenic orthostatic hypotension).
  • The subject manifests one of the following symptoms while standing or has a history of one of the following when not treated for orthostatic hypotension: dizziness, lightheadedness, feeling faint or feeling like they may black out.
  • The subject is willing and able to undergo the procedures required by this protocol including morning office visits, assessment completion, protocol compliance and participation in the wash-out period.
  • The subject has signed an Institutional-Review-Board approved written informed consent form prior to any study procedures taking place.

Exclusion Criteria

  • The subject is a pregnant or lactating female.
  • The subject has pre-existing sustained supine hypertension greater than 180 mm Hg systolic and 110 mm Hg diastolic.
  • The subject is taking medications such as vasodilators, pressors, diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers, combined alpha and beta-blockers, MAOI's, herbals or specific mixed effect medications.
  • The Principal Investigator deems any laboratory test abnormality clinical significant.
  • The subject has a diagnosis of any of the following disorders at the time of screening: pheochromocytoma; cardiac conditions including: congestive heart failure within the previous 6 months, myocardial infarction within the previous 6 months, symptomatic coronary artery disease, history of ventricular tachycardia, or uncontrolled cardiac arrhythmias; thyrotoxicosis; uncontrolled diabetes mellitus (uncontrolled defined as a HgbA1c greater than or equal to 10%); history of cerebrovascular accident, transient ischemic attack (TIA) or symptomatic carotid artery stenosis within the previous 6 months; history of coagulopathies; pulmonary hypertension; severe psychiatric disorders; renal failure (Creatinine equal to or greater than 2 times the upper limit of normal)
  • The subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of the tests and/or measurements administered in this trial, or that might increase the risk to the subject.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00555880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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