Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

NCT01515865 | Completed Phase 4 Results DMC

• 2 other identifiers: SPD426-4052012-005760-99
• Study Type: interventional
• Target: 98
• Locations: 4 countries
• Sites: 32

Brief Summary

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

Conditions

Symptomatic Orthostatic Hypotension

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects Who Failed to Maintain a Response

  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.

  30 minutes post-dose on Day 16

Study Arms (2)

Midodrine HCl

EXPERIMENTAL

Drug: Midodrine HCl

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Midodrine HCl DRUG

dose at subject's current dose level

Also known as: ProAmatine®

Midodrine HCl

Placebo DRUG

single dose of matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects must be 18 years of age or older and ambulatory.
• Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test.
• 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.
• 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.

You may not qualify if:

• The subject is a pregnant or lactating female.
• 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.
• 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.
• The Principal Investigator deems any clinical laboratory test (at the Screening Visit) abnormality to be clinically significant
• 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).
• 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.
• 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.
• Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.
• Prior enrollment failure or randomization in this study.
• History of alcohol abuse or other substance abuse within the last year.

Sponsors & Collaborators

• Shire: lead

Study Sites (32)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Location

Pharmaseek-Burbank

North Hollywood, California, 91606, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Advance Research Institute Inc

New Port Richey, Florida, 34653, United States

Location

DMI Reasearch Inc

Pinellas Park, Florida, 33782, United States

Location

Parkinson's Disease Treatment Center of Southwest Florida

Port Charlotte, Florida, 33980, United States

Location

Chicago Medical VA

North Chicago, Illinois, 60064, United States

Location

Analab Clinical Research Inc

Lenexa, Kansas, 66219, United States

Location

PAREXEL International - Baltimore EPCU Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

Frontage Clinical Services

Hackensack, New Jersey, 07601, United States

Location

Buffalo Clinical Research Center (BCRC)

Buffalo, New York, 14202, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Kidney and Hypertension Center

Roseburg, Oregon, 97471, United States

Location

New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

UT South West Medical Center

Dallas, Texas, 75390, United States

Location

The Heartbeat Clinic, PA

McKinney, Texas, 75069, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Fakultní nemocnice Hradec Králové

Hradec, Králové, 500 05, Czechia

Location

Fakultní nemocnice Ostrava

Ostrava, Poruba, 708 52, Czechia

Location

Fakultní nemocnice v Motole

Prague, 150 06, Czechia

Location

EMC Silesia Sp. z o.o.; NZOZ Szpital Geriatryczny im. Jana Pawła II w Katowicach

Katowice, 40-353, Poland

Location

Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala, + satelite site:NZOZ Szpital Avimed Sp. z o.o.

Katowice, 40-588, Poland

Location

Centrum Medyczne HCP, Lecznictwo Stacjonarne, Oddział Udarowy

Poznan, 61-485, Poland

Location

MTZ Clinical Research Sp. z o.o.

Warsaw, 02-106, Poland

Location

Wojskowy Instytut Medyczny, Klinika Neurologiczna

Warsaw, 04-141, Poland

Location

Neurologická klinika SZU a UNB, Univerzitná nemocnica Bratislava

Bratislava, 826 06, Slovakia

Location

Neurologická klinika UN Martin, Univerzitná nemocnica Martin

Martin, 036 59, Slovakia

Location

Neurologická klinika FN Nitra, Fakultná nemocnica Nitra

Nitra, 949 01, Slovakia

Location

Neurologické oddelenie, Nemocnica s poliklinikou Spišská Nová Ves, a.s.

Spišská Nová Ves, 052 01, Slovakia

Location

Neurologické oddelenie FN Trnava, Fakultná nemocnica Trnava

Trnava, 917 75, Slovakia

Location

Neurologické oddelenie FNsP Žilina, Fakultná nemocnica s poliklinikou Žilina

Žilina, 012 07, Slovakia

Location

MeSH Terms

Interventions

Midodrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 24, 2012
• Study Start: May 23, 2012
• Primary Completion: November 11, 2013
• Study Completion: November 11, 2013
• Last Updated: June 9, 2021
• Results First Posted: October 22, 2014

Record last verified: 2021-05

Locations

US (18); PL (5); SL (6); CZ (3)