Phase 4 N=87 Randomized Treatment

Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

Orthostatic; Hypotension, Neurogenic

Bottom Line

View on ClinicalTrials.gov: NCT02308124 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Change in Orthostatic BP Drop — 11.1; 13.6; 8.9; 7.5 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Midodrine (Drug); Pyridostigmine Bromide (Drug); Midodrine + pyridostigmine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Seoul National University Hospital
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Orthostatic BP Drop	11.1; 13.6; 8.9; 7.5; 11.1; 7.4	—
SECONDARY Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).	-16.2; -17.2; -12.6	—
SECONDARY Change of the Depression Score (Beck Depression Inventory-II )	-6.8; -7.8; -3.5	—
SECONDARY Short-form 36 Version 2	5.6; 4.2; 2.7	—
SECONDARY Changes in Health-related Quality of Life	5.0; 6.7; 0.4	—

Summary

Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.

Eligibility Criteria

Inclusion Criteria

age >=18 patients who complained of dizziness
Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10

Exclusion Criteria

Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
Heart failure or Chronic renal failure
Patients who cannot or do not want to write questionaires.
Poor drug compliance

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Data sourced from ClinicalTrials.gov (NCT02308124). 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.