Clinical trial NCT01515865: Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
Official title: A Phase 4, Randomized-withdrawal, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects With Symptomatic Orthostatic Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Symptomatic Orthostatic Hypotension
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent of Subjects Who Failed to Maintain a Response
timeFrame: 30 minutes post-dose on Day 16
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
city: North Hollywood
country: United States
facility: Pharmaseek-Burbank
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: New Port Richey
country: United States
facility: Advance Research Institute Inc
state: Florida
city: Pinellas Park
country: United States
facility: DMI Reasearch Inc
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of Southwest Florida
state: Florida
city: North Chicago
country: United States
facility: Chicago Medical VA
state: Illinois
city: Lenexa
country: United States
facility: Analab Clinical Research Inc
state: Kansas
city: Baltimore
country: United States
facility: PAREXEL International - Baltimore EPCU Harbor Hospital
state: Maryland
city: Hackensack
country: United States
facility: Frontage Clinical Services
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo Clinical Research Center (BCRC)
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Roseburg
country: United States
facility: Kidney and Hypertension Center
state: Oregon
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research - Knoxville
state: Tennessee
city: Dallas
country: United States
facility: UT South West Medical Center
state: Texas
city: McKinney
country: United States
facility: The Heartbeat Clinic, PA
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Hradec
country: Czechia
facility: Fakultní nemocnice Hradec Králové
state: Králové
city: Ostrava
country: Czechia
facility: Fakultní nemocnice Ostrava
state: Poruba
city: Praha
country: Czechia
facility: Fakultní nemocnice v Motole
city: Katowice
country: Poland
facility: EMC Silesia Sp. z o.o.; NZOZ Szpital Geriatryczny im. Jana Pawła II w Katowicach
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala, + satelite site:NZOZ Szpital Avimed Sp. z o.o.
city: Poznań
country: Poland
facility: Centrum Medyczne HCP, Lecznictwo Stacjonarne, Oddział Udarowy
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny, Klinika Neurologiczna
city: Bratislava
country: Slovakia
facility: Neurologická klinika SZU a UNB, Univerzitná nemocnica Bratislava
city: Martin
country: Slovakia
facility: Neurologická klinika UN Martin, Univerzitná nemocnica Martin
city: Nitra
country: Slovakia
facility: Neurologická klinika FN Nitra, Fakultná nemocnica Nitra
city: Spišská Nová Ves
country: Slovakia
facility: Neurologické oddelenie, Nemocnica s poliklinikou Spišská Nová Ves, a.s.
city: Trnava
country: Slovakia
facility: Neurologické oddelenie FN Trnava, Fakultná nemocnica Trnava
city: Žilina
country: Slovakia
facility: Neurologické oddelenie FNsP Žilina, Fakultná nemocnica s poliklinikou Žilina
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: