Orthostatic HypertensionPhase 1/2NCT01285908
Intravenous Norepinephrine for Orthostatic Hypotension
A Phase 1/2 study testing Intravenous Norepinephrine Infusion in people with Orthostatic Hypertension, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex action of the automatic nervous system makes blood vessels tighten when people stand up. The nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps blood pressure in check. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypertension
- What is being tested?
- Intravenous Norepinephrine Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2012
- Phase
- Phase 1/2
- 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
- A candidate subject is eligible for inclusion if he or she satisfies all of the following criteria:
- Aged 18 years or over.
- A confirmed diagnosis of neurogenic orthostatic hypotension related to Parkinson disease or pure autonomic failure.
- Able to provide informed consent
Who cannot join
- A candidate subject is ineligible for inclusion if he or she satisfies any of the following criteria:
- Receiving medications expected to augment or attenuate blood pressure responses to i.v. norepinephrine (such as tricyclic antidepressants or alpha-adrenoceptor blockers).
- Has heart block (unless a functioning cardiac pacemaker is in place or the patient is cleared by a cardiologist).
- Raynaud's phenomenon or other findings in the medical history suggest a tendency to vasospasm.
- History of myocardial infarction or current evidence of symptomatic congestive heart failure or symptomatic coronary ischemia.
- Current evidence of ventricular arrhythmias or frequent premature ventricular contractions.
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- Renal failure.
- History of mesenteric ischemia.
- History of cerebrovascular ischemic disease, unless corrected (e.g., by stent).
- Technical or medicinal limitations that obviate safe placement of arm intravenous and intra-arterial catheters for drug infusion and blood drawing. Examples of medicinal limitations are required daily aspirin ingestion and previously documented lidocaine allergy.
- Pregnant or lactating or a female of child bearing potential who refuses to have a blood test for pregnancy. (Urine pregnancy tests can yield false-negative results, due to incorrect test preparation, urine that is too dilute, or interference by several medications. We have experience with the NIH Clinical Pathology Department not calling a urine test for pregnancy positive or negative because the urine was dilute. Serum pregnancy tests do not have these limitations.)
- Unable to tolerate lying supine on a tilt table.
- Closed angle glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Safety and Efficacy of Intravenous Norepinephrine for Orthostatic Hypotension
Background:
- Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex action of the automatic nervous system makes blood vessels tighten when people stand up. The nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps blood pressure in check. In orthostatic hypotension, the nervous system does not release enough norepinephrine when a person stands up, which can cause fainting or falling. Researchers are interested in determining whether norepinephrine given as a drug by vein can help maintain blood pressure during changes in body position.
Read more
Objectives:
- To determine whether intravenous norepinephrine can maintain blood pressure in people with orthostatic hypotension.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with orthostatic hypotension related to Parkinson's disease or pure autonomic failure.
Design:
- This study will require a 2-day inpatient admission to the NIH Clinical Center. The first day will involve laboratory evaluation and the second day will involve testing with norepinephrine. The second day requires an overnight stay.
- Participants will be screened with a medical history and physical examination, blood samples, and an electrocardiogram or echocardiogram.
- Participants who are on medications may be asked to taper or discontinue one or more medications for the purposes of this study. Participants may not take aspirin or any drugs that slow blood clotting for 7 days before study participation.
- Day 1: Participants will have a clear liquid breakfast, and will have a 1-hour baseline tilt table test to monitor blood flow, skin temperature, sweating, and blood pressure. Body temperature and breathing will also be monitored.
- Day 2: Participants will have a clear liquid breakfast, and will have a 2-hour tilt table test. Initial blood pressure readings will be taken, and an intravenous line will be placed. Participants will then receive norepinephrine or saline, followed by additional position changes of the tilt table to measure blood pressure differences before returning to the starting position. After about 10 minutes, the tilt table testing and infusion will be repeated with the other drug (saline or norepinephrine).
- Participants will be discharged 24 hours after the testing is complete.
Read the detailed description
Objective:
Patients with chronic autonomic failure (CAF) often have disabling orthostatic hypotension (OH). In CAF, OH results from deficient baroreflex-mediated release of norepinephrine (NE) from sympathetic nerves. In patients with pure autonomic failure (PAF) or Parkinson disease (PD) with OH, cardiac and extra-cardiac noradrenergic denervation exacerbates effects of baroreflex failure. OH in CAF patients is often associated with supine hypertension, which can be severe. Drugs to treat OH worsen supine hypertension. Therefore, the combination of OH with supine hypertension poses a difficult therapeutic challenge. This protocol is a first step toward development of a prosthetic baroreceptor system to maintain blood pressure during orthostasis without worsening supine hypertension. In patients with PAF or PD+OH NE is infused i.v. at doses titrated individually to maintain blood pressure during head-up tilt at increasing angles from horizontal. Blood pressure is monitored continuously directly via an intra-arterial catheter. Because of the phenomenon of denervation supersensitivity, we anticipate that patients with OH associated with sympathetic noradrenergic denervation, as in PAF and PD, should be especially responsive to i.v. norepinephrine.
Study Population:
Patients with Parkinson disease and orthostatic hypotension or with pure autonomic failure.
Design:
This is a placebo controlled study that consists of two experimental days per participant. On a day before the day of norepinephrine (NE) infusion, the patient undergoes head-up tilting (typically at 15, 30, 45, and 60 degrees from horizontal) while blood pressure is monitored. Tilt angles are increased until the patient has orthostatic symptoms, systolic pressure decreases to less than 90 mm Hg, or systolic pressure decreases by more than 80 mm Hg. On the day of NE infusion patients, receive NE and placebo with the sequence of treatments randomized. If the patient has severe supine hypertension (more than 200 mm Hg systolic), then NE is infused beginning with the patient at whatever tilt angle is required for baseline pressure to be less than 200 mm Hg. NE is infused at doses titrated to keep directly recorded systolic blood pressure at or above the baseline value during exposure to higher tilt angles. When placebo is given, angles of tilt are increased until the patient has orthostatic symptoms, systolic pressure decreases to less than 90 mm Hg, or systolic pressure decreases by more than 80 mm Hg.
Outcome Measures:
The extent to which NE infusion can maintain blood pressure is tested by comparison of the fractional changes in systolic blood pressure at the same tilt angles during NE infusion vs. placebo infusion.
Primary:
- Blood pressures (systolic, diastolic, mean)
- Symptoms of orthostatic intolerance
Secondary:
- Hemodynamics (e.g., total peripheral resistance)
- Arterial plasma levels of norepinephrine and related neurochemicals
Comparison:
Patients undergo head-up tilt at the same angles to verify orthostatic hypotension if norepinephrine is not infused.
Participating Sites:
The study is done in the NIH Clinical Center in Bethesda, MD.
Contact Information:
The Principal Investigator is David S. Goldstein, MD PhD, Chief, Clinical Neurocardiology Section, CNP/DIR/NINDS/NIH, phone 301-496-2103, e-mail goldsteind@ninds.nih.gov. The contact for patient care coordination is Tereza Jenkins, phone 301-496-1115, e-mail jenkinst@ninds.nih.gov. The research contact (e.g., for database coordination) is Sandra Pechnik, phone 301-435-5166, e-mail pechniks@ninds.nih.gov.
- Conditions
- Orthostatic Hypertension
- Being tested
- Intravenous Norepinephrine Infusion
- Keywords
- Baroreceptor, Norepinephrine, Orthostatic Hypotension, Sympathetic Nervous System, Blood Pressure
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Norepinephrine InfusionDrug
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Baseline values measured at various tilt angles, so that each participant may serve as their own control. |
| Saline infusion | Placebo comparator | Subjects received a saline IV infusion as a placebo, while measurements were taken at various tilt angles. Receives: Drug: Intravenous Norepinephrine Infusion |
| Norepinephrine Infusion | Active comparator | Subjects were given an norepinephrine infusion at various tilt angles, while measurements were taken. Receives: Drug: Intravenous Norepinephrine Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (Systolic)
The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.
Measured: 2 experimental days
Blood Pressure (Diastolic)
The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in diastolic pressure at varying tilt angles during baseline and saline infusion.
Measured: 2 experimental days
Blood Pressure (Mean)
The extent to which norepinephrine infusion maintains average blood pressure, by comparison with the fractional changes in blood pressure at varying tilt angles during baseline and saline infusion.
Measured: 2 experimental days
Secondary outcomes (6)
Heart Rate
The extent to which norepinephrine infusion affects heart rate, by comparison of beat-to-beat heart rate at varying tilt angles during baseline and saline infusion.
Measured: 2 experimental days
Cardiac Stroke Volume
The extent to which norepinephrine infusion affects cardiac stroke volume, by comparison of cardiac stroke volume at varying tilt angles during baseline and saline infusion.
Measured: 2 experimental days
Cardiac Output
The extent to which norepinephrine infusion affects cardiac output, by comparison of cardiac output at varying tilt angles during baseline and saline infusion.
Measured: 2 experimental days
Total Peripheral Resistance
The extent to which norepinephrine infusion affected total peripheral resistance, by comparison of total peripheral resistance at varying tilt angles during baseline and saline infusion.
Measured: 2 experimental days
Arterial Plasma Levels of Norepinephrine
Plasma levels of norepinephrine are obtained from blood samples via IV catheter.
Measured: 2 experimental days
Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)
Plasma levels of dihydroxyphenylglycol are obtained from blood samples via IV catheter.
Measured: 2 experimental days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionSep 2012
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthostatic HypertensionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lawrence Latour, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285908
- Sponsor's protocol ID
- 110085
- Other IDs
- 11-N-0085
- Status last verified
- Sep 2014
- First submitted
- 25 Jan 2011
- Last updated
- 10 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Polinsky RJ, Samaras GM, Kopin IJ. Sympathetic neural prosthesis for managing orthostatic hypotension. Lancet. 1983 Apr 23;1(8330):901-4. doi: 10.1016/s0140-6736(83)91329-6.
PubMed 6132222Oldenburg O, Mitchell A, Nurnberger J, Koeppen S, Erbel R, Philipp T, Kribben A. Ambulatory norepinephrine treatment of severe autonomic orthostatic hypotension. J Am Coll Cardiol. 2001 Jan;37(1):219-23. doi: 10.1016/s0735-1097(00)01062-7.
PubMed 11153742Goldstein DS, Horwitz D, Keiser HR, Polinsky RJ, Kopin IJ. Plasma l-[3H]norepinephrine, d-[14C]norepinephrine, and d,l-[3H]isoproterenol kinetics in essential hypertension. J Clin Invest. 1983 Nov;72(5):1748-58. doi: 10.1172/JCI111134.
PubMed 6630523Goldstein DS, Sewell L, Holmes C, Pechnik S, Diedrich A, Robertson D. Temporary elimination of orthostatic hypotension by norepinephrine infusion. Clin Auton Res. 2012 Dec;22(6):303-6. doi: 10.1007/s10286-012-0176-4. Epub 2012 Sep 16.
PubMed 22983778
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravenous Norepinephrine for Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT01285908
- Acronym / sponsor ID
- 110085
- Conditions
- Orthostatic Hypertension
- Keywords
- Baroreceptor, Norepinephrine, Orthostatic Hypotension, Sympathetic Nervous System, Blood Pressure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Posted 26 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex action of the automatic nervous system makes blood vessels tighten when people stand up. The nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps blood pressure in check. In orthostatic hypotension, the nervous system does not release enough norepinephrine when a person stands up, which can cause fainting or falling. Researchers are interested in determining whether norepinephrine given as a drug by vein can help maintain blood pressure during changes in body position.
Objectives:
- To determine whether intravenous norepinephrine can maintain blood pressure in people with orthostatic hypotension.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with orthostatic hypotension related to Parkinson's disease or pure autonomic failure.
Design:
- This study will require a 2-day inpatient admission to the NIH Clinical Center. The first day will involve laboratory evaluation and the second day will involve testing with norepinephrine. The second day requires an overnight stay.
- Participants will be screened with a medical history and physical examination, blood samples, and an electrocardiogram or echocardiogram.
- Participants who are on medications may be asked to taper or discontinue one or more medications for the purposes of this study. Participants may not take aspirin or any drugs that slow blood clotting for 7 days before study participation.
- Day 1: Participants will have a clear liquid breakfast, and will have a 1-hour baseline tilt table test to monitor blood flow, skin temperature, sweating, and blood pressure. Body temperature and breathing will also be monitored.
- Day 2: Participants will have a clear liquid breakfast, and will have a 2-hour tilt table test. Initial blood pressure readings will be taken, and an intravenous line will be placed. Participants will then receive norepinephrine or saline, followed by additional position changes of the tilt table to measure blood pressure differences before returning to the starting position. After about 10 minutes, the tilt table testing and infusion will be repeated with the other drug (saline or norepinephrine).
- Participants will be discharged 24 hours after the testing is complete.
Detailed description
Objective:
Patients with chronic autonomic failure (CAF) often have disabling orthostatic hypotension (OH). In CAF, OH results from deficient baroreflex-mediated release of norepinephrine (NE) from sympathetic nerves. In patients with pure autonomic failure (PAF) or Parkinson disease (PD) with OH, cardiac and extra-cardiac noradrenergic denervation exacerbates effects of baroreflex failure. OH in CAF patients is often associated with supine hypertension, which can be severe. Drugs to treat OH worsen supine hypertension. Therefore, the combination of OH with supine hypertension poses a difficult therapeutic challenge. This protocol is a first step toward development of a prosthetic baroreceptor system to maintain blood pressure during orthostasis without worsening supine hypertension. In patients with PAF or PD+OH NE is infused i.v. at doses titrated individually to maintain blood pressure during head-up tilt at increasing angles from horizontal. Blood pressure is monitored continuously directly via an intra-arterial catheter. Because of the phenomenon of denervation supersensitivity, we anticipate that patients with OH associated with sympathetic noradrenergic denervation, as in PAF and PD, should be especially responsive to i.v. norepinephrine.
Study Population:
Patients with Parkinson disease and orthostatic hypotension or with pure autonomic failure.
Design:
This is a placebo controlled study that consists of two experimental days per participant. On a day before the day of norepinephrine (NE) infusion, the patient undergoes head-up tilting (typically at 15, 30, 45, and 60 degrees from horizontal) while blood pressure is monitored. Tilt angles are increased until the patient has orthostatic symptoms, systolic pressure decreases to less than 90 mm Hg, or systolic pressure decreases by more than 80 mm Hg. On the day of NE infusion patients, receive NE and placebo with the sequence of treatments randomized. If the patient has severe supine hypertension (more than 200 mm Hg systolic), then NE is infused beginning with the patient at whatever tilt angle is required for baseline pressure to be less than 200 mm Hg. NE is infused at doses titrated to keep directly recorded systolic blood pressure at or above the baseline value during exposure to higher tilt angles. When placebo is given, angles of tilt are increased until the patient has orthostatic symptoms, systolic pressure decreases to less than 90 mm Hg, or systolic pressure decreases by more than 80 mm Hg.
Outcome Measures:
The extent to which NE infusion can maintain blood pressure is tested by comparison of the fractional changes in systolic blood pressure at the same tilt angles during NE infusion vs. placebo infusion.
Primary:
- Blood pressures (systolic, diastolic, mean)
- Symptoms of orthostatic intolerance
Secondary:
- Hemodynamics (e.g., total peripheral resistance)
- Arterial plasma levels of norepinephrine and related neurochemicals
Comparison:
Patients undergo head-up tilt at the same angles to verify orthostatic hypotension if norepinephrine is not infused.
Participating Sites:
The study is done in the NIH Clinical Center in Bethesda, MD.
Contact Information:
The Principal Investigator is David S. Goldstein, MD PhD, Chief, Clinical Neurocardiology Section, CNP/DIR/NINDS/NIH, phone 301-496-2103, e-mail goldsteind@ninds.nih.gov. The contact for patient care coordination is Tereza Jenkins, phone 301-496-1115, e-mail jenkinst@ninds.nih.gov. The research contact (e.g., for database coordination) is Sandra Pechnik, phone 301-435-5166, e-mail pechniks@ninds.nih.gov.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Baseline values measured at various tilt angles, so that each participant may serve as their own control. |
| Saline infusion | Placebo comparator | Drug: Intravenous Norepinephrine InfusionSubjects received a saline IV infusion as a placebo, while measurements were taken at various tilt angles. |
| Norepinephrine Infusion | Active comparator | Drug: Intravenous Norepinephrine InfusionSubjects were given an norepinephrine infusion at various tilt angles, while measurements were taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A candidate subject is eligible for inclusion if he or she satisfies all of the following criteria:
- Aged 18 years or over.
- A confirmed diagnosis of neurogenic orthostatic hypotension related to Parkinson disease or pure autonomic failure.
- Able to provide informed consent
Key exclusion criteria (13 listed)
- A candidate subject is ineligible for inclusion if he or she satisfies any of the following criteria:
- Receiving medications expected to augment or attenuate blood pressure responses to i.v. norepinephrine (such as tricyclic antidepressants or alpha-adrenoceptor blockers).
- Has heart block (unless a functioning cardiac pacemaker is in place or the patient is cleared by a cardiologist).
- Raynaud's phenomenon or other findings in the medical history suggest a tendency to vasospasm.
- History of myocardial infarction or current evidence of symptomatic congestive heart failure or symptomatic coronary ischemia.
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 |
|---|---|---|
| Intravenous Norepinephrine Infusion | Drug | Norepinephrine Infusion, Saline infusion |
Primary outcome
Blood Pressure (Systolic)
Time frame: 2 experimental days
The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.
Blood Pressure (Diastolic)
Time frame: 2 experimental days
The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in diastolic pressure at varying tilt angles during baseline and saline infusion.
Blood Pressure (Mean)
Time frame: 2 experimental days
The extent to which norepinephrine infusion maintains average blood pressure, by comparison with the fractional changes in blood pressure at varying tilt angles during baseline and saline infusion.
6 secondary outcomes
Heart Rate
Time frame: 2 experimental days
Cardiac Stroke Volume
Time frame: 2 experimental days
Cardiac Output
Time frame: 2 experimental days
Total Peripheral Resistance
Time frame: 2 experimental days
Arterial Plasma Levels of Norepinephrine
Time frame: 2 experimental days
Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)
Time frame: 2 experimental days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6132222Polinsky RJ, Samaras GM, Kopin IJ. Sympathetic neural prosthesis for managing orthostatic hypotension. Lancet. 1983 Apr 23;1(8330):901-4. doi: 10.1016/s0140-6736(83)91329-6.
- Background: PubMed 11153742Oldenburg O, Mitchell A, Nurnberger J, Koeppen S, Erbel R, Philipp T, Kribben A. Ambulatory norepinephrine treatment of severe autonomic orthostatic hypotension. J Am Coll Cardiol. 2001 Jan;37(1):219-23. doi: 10.1016/s0735-1097(00)01062-7.
- Background: PubMed 6630523Goldstein DS, Horwitz D, Keiser HR, Polinsky RJ, Kopin IJ. Plasma l-[3H]norepinephrine, d-[14C]norepinephrine, and d,l-[3H]isoproterenol kinetics in essential hypertension. J Clin Invest. 1983 Nov;72(5):1748-58. doi: 10.1172/JCI111134.
- Background: PubMed 22983778Goldstein DS, Sewell L, Holmes C, Pechnik S, Diedrich A, Robertson D. Temporary elimination of orthostatic hypotension by norepinephrine infusion. Clin Auton Res. 2012 Dec;22(6):303-6. doi: 10.1007/s10286-012-0176-4. Epub 2012 Sep 16.
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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.
Lawrence Latour, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous Norepinephrine Infusion in people with Orthostatic Hypertension, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 13 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 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Mar 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?
Blood Pressure (Systolic) (time frame: 2 experimental days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01285908, which also lists 4 linked publications.
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 10 Oct 2014.