HypertensionPhase 4ATRAXNCT02641652
A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension
A Phase 4 study testing Sertraline in people with Hypertension, run by University Hospital Olomouc.
Trial summary
There is currently no established treatment for paroxysmal hypertension, but selective serotonin reuptake inhibitors showed good effect in previous reports. This double-blind, placebo controlled, prospective multicenter clinical trial will assess the efficacy of sertraline on cessation or reduction of symptoms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Study will enroll adult patients (age >18 years) with hypertensive paroxysms during the past 6 months (preferably during the past 6 weeks) - abrupt elevations of systolic blood pressure (BP) ≥20% compared to previous measured systolic BP value before paroxysm, or ≥20% compared to mean systolic BP on 24-hour ambulatory blood pressure monitoring (ABPM), or ≥20% compared to measured office systolic BP, documented by a clinician or home blood pressure monitor, requiring physician or emergency room visit or the use of any rescue antihypertensive medication. Hypertensive paroxysms may be accompanied by abrupt onset of one or more distressful physical symptoms, such as headache, chest pain, dizziness, nausea, palpitations, flushing, and diaphoresis.
Who cannot join
- Pregnancy or breastfeeding, hypersensitivity to sertraline (Zoloft®) or of the the components of this drug. Current use of sertraline or any other selective serotonin reuptake inhibitor (SSRI), mono-amin oxidase (MAO) inhibitors, selegiline, moclobemide, linezolide, pimozide. Current use of other serotoninergic drugs (eg. tryptofane, triptane and other 5-HT agonists), tramadol or dopamine antagonists (including antipsychotics).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension (ATRAX Trial)
There is currently no established treatment for paroxysmal hypertension, but selective serotonin reuptake inhibitors showed good effect in previous reports. This double-blind, placebo controlled, prospective multicenter clinical trial will assess the efficacy of sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136 patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated after 3 months. If proven effective, sertraline might become a standard treatment for this condition.
- Conditions
- Hypertension
- Being tested
- Sertraline, Placebo
- Keywords
- paroxysmal hypertension, pseudopheochromocytoma
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial
PlaceboDrug
1/2 tablet once daily for first 7 days, then 1 tablet once daily for the rest of the trial
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Active comparator | sertraline, 25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial Receives: Drug: Sertraline |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups
Measured: 3 months of treatment
difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups
Measured: 3 months
Secondary outcomes (2)
difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups
Measured: 3 months
side effects of the treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startNov 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, St. Anne, University Hospital Ostrava, Tomas Bata Hospital, Czech Republic, Prerov Hospital, Valasske Mezirici Hospital, Thomayer University Hospital, Vsetin Hospital
- Responsible party
- Principal investigator, Jan Vaclavík, Palacky University
- Investigators
- Jan Vaclavik, MD. Ph.D. Assoc. Prof, Study chair, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641652
- Sponsor's protocol ID
- ATRAX
- Acronym
- ATRAX
- Status last verified
- Sep 2017
- First submitted
- 22 Dec 2015
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma): understanding the cause and treatment. Arch Intern Med. 1999 Apr 12;159(7):670-4. doi: 10.1001/archinte.159.7.670.
PubMed 10218745Eisenhofer G, Sharabi Y, Pacak K. Unexplained symptomatic paroxysmal hypertension in pseudopheochromocytoma: a stress response disorder? Ann N Y Acad Sci. 2008 Dec;1148:469-78. doi: 10.1196/annals.1410.019.
PubMed 19120143Pickering TG, Clemow L. Paroxysmal hypertension: the role of stress and psychological factors. J Clin Hypertens (Greenwich). 2008 Jul;10(7):575-81. doi: 10.1111/j.1751-7176.2008.07844.x.
PubMed 18607143Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma). Curr Hypertens Rep. 2008 Feb;10(1):12-8. doi: 10.1007/s11906-008-0005-2.
PubMed 18367021
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension (ATRAX Trial)
- ClinicalTrials.gov ID
- NCT02641652
- Acronym / sponsor ID
- ATRAX / ATRAX
- Conditions
- Hypertension
- Keywords
- paroxysmal hypertension, pseudopheochromocytoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Brno University Hospital, St. Anne, University Hospital Ostrava, Tomas Bata Hospital, Czech Republic, Prerov Hospital, Valasske Mezirici Hospital, Thomayer University Hospital, Vsetin Hospital
- Study start
- Nov 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is currently no established treatment for paroxysmal hypertension, but selective serotonin reuptake inhibitors showed good effect in previous reports. This double-blind, placebo controlled, prospective multicenter clinical trial will assess the efficacy of sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136 patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated after 3 months. If proven effective, sertraline might become a standard treatment for this condition.
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 |
|---|---|---|
| Sertraline | Active comparator | Drug: Sertralinesertraline, 25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study will enroll adult patients (age >18 years) with hypertensive paroxysms during the past 6 months (preferably during the past 6 weeks) - abrupt elevations of systolic blood pressure (BP) ≥20% compared to previous measured systolic BP value before paroxysm, or ≥20% compared to mean systolic BP on 24-hour ambulatory blood pressure monitoring (ABPM), or ≥20% compared to measured office systolic BP, documented by a clinician or home blood pressure monitor, requiring physician or emergency room visit or the use of any rescue antihypertensive medication. Hypertensive paroxysms may be accompanied by abrupt onset of one or more distressful physical symptoms, such as headache, chest pain, dizziness, nausea, palpitations, flushing, and diaphoresis.
Key exclusion criteria (1 listed)
- Pregnancy or breastfeeding, hypersensitivity to sertraline (Zoloft®) or of the the components of this drug. Current use of sertraline or any other selective serotonin reuptake inhibitor (SSRI), mono-amin oxidase (MAO) inhibitors, selegiline, moclobemide, linezolide, pimozide. Current use of other serotoninergic drugs (eg. tryptofane, triptane and other 5-HT agonists), tramadol or dopamine antagonists (including antipsychotics).
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 |
|---|---|---|
| Sertraline25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial | Drug | Sertraline |
| Placebo1/2 tablet once daily for first 7 days, then 1 tablet once daily for the rest of the trial | Drug | Placebo |
Primary outcome
difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups
Time frame: 3 months of treatment
difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups
Time frame: 3 months
2 secondary outcomes
difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups
Time frame: 3 months
side effects of the treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Background: PubMed 10218745Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma): understanding the cause and treatment. Arch Intern Med. 1999 Apr 12;159(7):670-4. doi: 10.1001/archinte.159.7.670.
- Background: PubMed 19120143Eisenhofer G, Sharabi Y, Pacak K. Unexplained symptomatic paroxysmal hypertension in pseudopheochromocytoma: a stress response disorder? Ann N Y Acad Sci. 2008 Dec;1148:469-78. doi: 10.1196/annals.1410.019.
- Background: PubMed 18607143Pickering TG, Clemow L. Paroxysmal hypertension: the role of stress and psychological factors. J Clin Hypertens (Greenwich). 2008 Jul;10(7):575-81. doi: 10.1111/j.1751-7176.2008.07844.x.
- Background: PubMed 18367021Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma). Curr Hypertens Rep. 2008 Feb;10(1):12-8. doi: 10.1007/s11906-008-0005-2.
- University Hospital OlomoucLink provided by the sponsor.
- Faculty of Medicine and Dentistry, Palacký UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jan Vaclavik, MD. Ph.D. Assoc. Prof study chair
University Hospital Olomouc
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline in people with Hypertension, run by University Hospital Olomouc.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Vaclavik, MD. Ph.D. Assoc. Prof. (+420588442682, janvaclavik@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups (time frame: 3 months of treatment). The study lists 2 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 NCT02641652, 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 8 Sep 2017.