Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

NCT ID: NCT01515865

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-23
• Study Completion Date: 2013-11-11

Brief Summary

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

Detailed Description

The efficacy of midodrine will be assessed in those subjects who have severe symptoms of orthostatic hypotension when not taking midodrine and are controlled when taking midodrine. The study will involve approximately 9 overnight stays.

Conditions

Symptomatic Orthostatic Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Midodrine HCl

Group Type: EXPERIMENTAL

Midodrine HCl

Intervention Type: DRUG

dose at subject's current dose level

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single dose of matching placebo

Interventions

Midodrine HCl

dose at subject's current dose level

Intervention Type: DRUG

Placebo

single dose of matching placebo

Intervention Type: DRUG

Other Intervention Names

ProAmatine®

Eligibility Criteria

Inclusion Criteria

1. Male and female subjects must be 18 years of age or older and ambulatory.

2. Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test.

3. 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.

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.

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 (at the Screening Visit) abnormality to be 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 SPD426-406).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

California Clinical Trials Medical Group

Glendale, California, United States

Pharmaseek-Burbank

North Hollywood, California, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Advance Research Institute Inc

New Port Richey, Florida, United States

DMI Reasearch Inc

Pinellas Park, Florida, United States

Parkinson's Disease Treatment Center of Southwest Florida

Port Charlotte, Florida, United States

Chicago Medical VA

North Chicago, Illinois, United States

Analab Clinical Research Inc

Lenexa, Kansas, United States

PAREXEL International - Baltimore EPCU Harbor Hospital

Baltimore, Maryland, United States

Frontage Clinical Services

Hackensack, New Jersey, United States

Buffalo Clinical Research Center (BCRC)

Buffalo, New York, United States

Columbia University

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Kidney and Hypertension Center

Roseburg, Oregon, United States

New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, United States

UT South West Medical Center

Dallas, Texas, United States

The Heartbeat Clinic, PA

McKinney, Texas, United States

Aspen Clinical Research

Orem, Utah, United States

Fakultní nemocnice Hradec Králové

Hradec, Králové, Czechia

Fakultní nemocnice Ostrava

Ostrava, Poruba, Czechia

Fakultní nemocnice v Motole

Prague, , Czechia

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

Katowice, , Poland

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

Katowice, , Poland

Centrum Medyczne HCP, Lecznictwo Stacjonarne, Oddział Udarowy

Poznan, , Poland

MTZ Clinical Research Sp. z o.o.

Warsaw, , Poland

Wojskowy Instytut Medyczny, Klinika Neurologiczna

Warsaw, , Poland

Neurologická klinika SZU a UNB, Univerzitná nemocnica Bratislava

Bratislava, , Slovakia

Neurologická klinika UN Martin, Univerzitná nemocnica Martin

Martin, , Slovakia

Neurologická klinika FN Nitra, Fakultná nemocnica Nitra

Nitra, , Slovakia

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

Spišská Nová Ves, , Slovakia

Neurologické oddelenie FN Trnava, Fakultná nemocnica Trnava

Trnava, , Slovakia

Neurologické oddelenie FNsP Žilina, Fakultná nemocnica s poliklinikou Žilina

Žilina, , Slovakia

Countries

United States; Czechia; Poland; Slovakia

Other Identifiers

2012-005760-99

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPD426-405

Identifier Type: -

Identifier Source: org_study_id