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Endothelin Receptor Antagonist

Bosentan for Stress-Related High Blood Pressure (End-Stress Trial)

N/A
Waitlist Available
Led By Ryan Harris, Ph.D.
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lean adults (BMl <25 kg/m^)
Obese adults (BMl > 30 kg/m^)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 days
Awards & highlights

End-Stress Trial Summary

This trial will study how our bodies respond to stress by looking at the role of endothelin-1.

Who is the study for?
This trial is for Black and White adults, ages 18-50, who are either lean (BMI < 25) or obese (BMI > 30). It's not for those on low-salt diets, with severe underweight or extreme obesity issues, cardiovascular diseases, pregnant women, uncontrolled high blood pressure patients, or those taking certain medications.Check my eligibility
What is being tested?
The study tests how a drug called Bosentan affects blood pressure response to stress compared to a placebo. The goal is to understand the role of endothelin-1 based on previous animal studies by the investigators.See study design
What are the potential side effects?
While specific side effects aren't listed here, Bosentan can generally cause liver problems, headache, anemia (low red blood cell count), respiratory tract infection and may interact with other medications.

End-Stress Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body mass index (BMI) is less than 25.
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I am considered obese with a BMI over 30.
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I am a man or a premenopausal woman aged between 18 and 50.
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My BMI is under 25.
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I am considered obese with a BMI over 30.

End-Stress Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Flow-Mediated Dilation (FMD)
Secondary outcome measures
Arterial Stiffness Evaluation (PWV)
Blood Pressure
Femoral blood flow
+2 more

Side effects data

From 2013 Phase 4 trial • 105 Patients • NCT00323297
14%
Diarrhoea
14%
Oedema peripheral
14%
Headache
10%
Vertigo
10%
Bronchitis
10%
Flushing
10%
Palpitations
10%
Nasopharyngitis
8%
Respiratory tract infection
6%
Pulmonary hypertension
6%
Depression
6%
Presyncope
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
4%
Anaemia
2%
Hypertension
2%
Cough
2%
Acute coronary syndrome
2%
Inguinal hernia
2%
Asthenia
2%
Cardiovascular disorder
2%
Mitral valve incompetence
2%
Gangrene
2%
Respiratory syncytial virus infection
2%
Urinary tract infection
2%
Walking distance test abnormal
2%
Breast cancer
2%
Uterine haemorrhage
2%
Haemoptysis
2%
Hypoxia
2%
Skin ulcer
2%
Nausea
2%
Back pain
2%
Death
2%
General physical health deterioration
2%
Circulatory collapse
2%
Cardiac failure
2%
Coronary artery disease
2%
Chest discomfort
2%
Pancreatic neoplasm
2%
Haemoglobin decreased
2%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil

End-Stress Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BosentanExperimental Treatment1 Intervention
Sub-Chronic (3 days) Bosentan 250mg/day.
Group II: PlaceboPlacebo Group1 Intervention
Stress response and endothelial function will be determined following a three day treatment of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bosentan
2010
Completed Phase 4
~1530

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor
210 Previous Clinical Trials
84,708 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,176 Total Patients Enrolled
Ryan Harris, Ph.D.Principal InvestigatorAugusta University
2 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Bosentan (Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02116335 — N/A
High Blood Pressure Research Study Groups: Placebo, Bosentan
High Blood Pressure Clinical Trial 2023: Bosentan Highlights & Side Effects. Trial Name: NCT02116335 — N/A
Bosentan (Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02116335 — N/A
High Blood Pressure Patient Testimony for trial: Trial Name: NCT02116335 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is participation in this medical trial open?

"This research is recruiting 320 individuals aged 18-50 with hypertension. To be accepted, participants must meet the following specifications: Lean adults (BMl <25 kg/m^), Obese adults (BMI > 30 kg/m^), and Men and premenopausal women."

Answered by AI

What therapeutic applications does Bosentan typically have?

"Bosentan is the recommended treatment for asthma, though it has also been used to ameliorate ocular inflammation and bacterial infections as well as thyroid cancer."

Answered by AI

Does this trial have an age restriction?

"Eligibility for this study is restricted to individuals aged 18-50."

Answered by AI

Is Bosentan being tested in any other experiments?

"Currently, 17 medical trials utilizing Bosentan are active throughout the world. Of these studies, 4 have advanced to Phase 3. Primarily situated around Xi'an in Shaanxi, there are a total of 53 research locations with clinical trials involving Bosentan underway."

Answered by AI

Are there still spots available for enrolment in this trial?

"The information provided on clinicaltrials.gov indicates that this medical experiment has concluded its recruitment phase. The trial was initially posted on June 1st 2015 and the most recent update occurred July 18th 2022. Despite not seeking participants anymore, there are still 764 other studies actively recruiting patients today."

Answered by AI

How many participants are taking part in this research endeavor?

"Unfortunately, this clinical trial has ended its recruitment process. First posted on June 1st 2015, the study was last updated on July 18th 2022. For other medical trials related to hypertension and Bosentan, there are presently 747 and 17 studies enrolling patients respectively."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
What site did they apply to?
Georgia Regents University

Why did patients apply to this trial?

I have just spoken with my doctor about changing my antidepressant medicine. Also, I am going through a lot of test for my heart.
PatientReceived 1 prior treatment
I am presently the spouse of a 78 year old husband who has just had an lvad placed at Piedmont of Atlanta. This was due to him being too risky for Piedmont of Augusta. Last March, my doctor Kellie Lane, put me on a half pill (half of a 5 mg) due to my BP, which normally was ok, starting to rise. She deemed this stress. On the 24th of August he had his Lvad surgery here in Atlanta. My stress level has been unmanageable and now I am taking a 5 mg in the morning and in the evening. BP is ranging between 136 and 160….bottom number usually 80. I know this is stress related and the pills aren’t doing much. His recuperation is very slow. Not sure when we will get back to Augusta. Just saw something on FB about a trial here at this hospital and also I think at Emory. But, if we get back, it would be nice to do it at AU. I am.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Endothelin Receptor Function and Acute Stress
Ryan Harris 2015. "Endothelin Receptor Function and Acute Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02116335.
All > Blood Pressure > High Blood Pressure
~48 spots leftby Dec 2025
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