Symptomatic Orthostatic HypotensionPhase 4NCT01515865
Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
A Phase 4 study testing Midodrine HCl in people with Symptomatic Orthostatic Hypotension, run by Shire at 32 sites in 4 countries.
Trial summary
To study the effect of midodrine against the symptoms of orthostatic hypotension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Orthostatic Hypotension
- What is being tested?
- Midodrine HCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 32 sitesin 4 countries
- Study dates
- 23 May 2012to 11 Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
United States18 sites
PAREXEL International - Baltimore EPCU Harbor Hospital
Baltimore, Maryland, 21225
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Buffalo Clinical Research Center (BCRC)
Buffalo, New York, 14202
Cleveland Clinic
Cleveland, Ohio, 44195
UT South West Medical Center
Dallas, Texas, 75390
California Clinical Trials Medical Group
Glendale, California, 91206
Frontage Clinical Services
Hackensack, New Jersey, 07601
New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, 37920
Analab Clinical Research Inc
Lenexa, Kansas, 66219
The Heartbeat Clinic, PA
McKinney, Texas, 75069
Advance Research Institute Inc
New Port Richey, Florida, 34653
Columbia University
New York, New York, 10032
Chicago Medical VA
North Chicago, Illinois, 60064
Pharmaseek-Burbank
North Hollywood, California, 91606
Aspen Clinical Research
Orem, Utah, 84058
DMI Reasearch Inc
Pinellas Park, Florida, 33782
Parkinson's Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, 33980
Kidney and Hypertension Center
Roseburg, Oregon, 97471
Slovakia6 sites
Neurologická klinika SZU a UNB, Univerzitná nemocnica Bratislava
Bratislava, 826 06
Neurologická klinika UN Martin, Univerzitná nemocnica Martin
Martin, 036 59
Neurologická klinika FN Nitra, Fakultná nemocnica Nitra
Nitra, 949 01
Neurologické oddelenie, Nemocnica s poliklinikou Spišská Nová Ves, a.s.
Spišská Nová Ves, 052 01
Neurologické oddelenie FN Trnava, Fakultná nemocnica Trnava
Trnava, 917 75
Neurologické oddelenie FNsP Žilina, Fakultná nemocnica s poliklinikou Žilina
Žilina, 012 07
Poland5 sites
EMC Silesia Sp. z o.o.; NZOZ Szpital Geriatryczny im. Jana Pawła II w Katowicach
Katowice, 40-353
Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala, + satelite site:NZOZ Szpital Avimed Sp. z o.o.
Katowice, 40-588
Centrum Medyczne HCP, Lecznictwo Stacjonarne, Oddział Udarowy
Poznan, 61-485
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106
Wojskowy Instytut Medyczny, Klinika Neurologiczna
Warsaw, 04-141
Czechia3 sites
Fakultní nemocnice Hradec Králové
Hradec, Králové, 500 05
Fakultní nemocnice Ostrava
Ostrava, Poruba, 708 52
Fakultní nemocnice v Motole
Prague, 150 06
About this study
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
To study the effect of midodrine against the symptoms of orthostatic hypotension
Read the 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
- Being tested
- Midodrine HCl, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine HClDrug
Also called ProAmatine®
dose at subject's current dose level
PlaceboDrug
single dose of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Midodrine HCl | Experimental | Not described Receives: Drug: Midodrine HCl |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes post-dose on Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study start23 May 2012
- Primary completion11 Nov 2013
- Study completion11 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptomatic Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515865
- Sponsor's protocol ID
- SPD426-405
- Other IDs
- 2012-005760-99
- Status last verified
- May 2021
- First submitted
- 18 Jan 2012
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01515865
- Acronym / sponsor ID
- SPD426-405
- Conditions
- Symptomatic Orthostatic Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 23 May 2012 (actual)
- Primary completion
- 11 Nov 2013 (actual)
- Study completion
- 11 Nov 2013 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 22 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine HCl | Experimental | Drug: Midodrine HCl |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midodrine HClAlso: ProAmatine®dose at subject's current dose level | Drug | Midodrine HCl |
| Placebosingle dose of matching placebo | Drug | Placebo |
Primary outcome
Percent of Subjects Who Failed to Maintain a Response
Time frame: 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 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midodrine HCl in people with Symptomatic Orthostatic Hypotension, run by Shire at 32 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Slovakia, Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Subjects Who Failed to Maintain a Response (time frame: 30 minutes post-dose on Day 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.