NCT01515865

Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

Completed Phase 4 Results posted Last updated 9 June 2021

What this trial tests

Phase 4 trial testing Midodrine HCl in Symptomatic Orthostatic Hypotension in 98 participants. Completed in 11 November 2013.

Timeline

23 May 2012

Primary endpoint
11 November 2013

11 November 2013

Quick facts

Lead sponsor	Shire
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	98
Start date	23 May 2012
Primary completion	11 November 2013
Estimated completion	11 November 2013
Sites	32 locations across Slovakia, United States, Poland, Czechia

Drugs / interventions tested

• Midodrine HCl
• Placebo

Conditions studied

• Symptomatic Orthostatic Hypotension — all drugs for Symptomatic Orthostatic Hypotension →

Sponsor

Shire — full company profile →

Who can join

18 and older, any sex, with Symptomatic Orthostatic Hypotension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Subjects Who Failed to Maintain a Response Primary · 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 consc

Group	Value	95% CI
Midodrine HCl	30.3
Placebo	44.1

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Midodrine HCl - Open-label (Part A)

Serious: 0/98 (0%)

Deaths: —

Midodrine HCl - Open-label (Part B)

Serious: 0/71 (0%)

Deaths: —

Midodrine HCl - Randomized (Part C)

Serious: 0/33 (0%)

Deaths: —

Placebo - Randomized (Part C)

Serious: 0/34 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	Midodrine HCl - Open-label…	Midodrine HCl - Open-label…	Midodrine HCl - Randomized…	Placebo - Randomized (Part…
Headache	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT01515865 adverse events section.

Sponsor's own description

To study the effect of midodrine against the symptoms of orthostatic hypotension

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study.
   Smith W, Wan H, Much D, Robinson AG, et al · · 2016 · cited 34× · PMID 27372462 · DOI 10.1007/s10286-016-0363-9