← Back to Search

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^)
Must not have
Using medications that affect vascular tone (i.e., nitrates, etc.)
Postmenopausal women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 days

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking medication that affects blood vessel function.
Select...
I am a woman who has gone through menopause.
Select...
My high blood pressure is not under control.
Select...
I have a history of rheumatoid arthritis.
Select...
I am not taking medications like glyburide or cyclosporine.
Select...
My BMI is either below 16 or above 40.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Flow-Mediated Dilation (FMD)
Secondary study objectives
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%
Flushing
10%
Bronchitis
10%
Nasopharyngitis
10%
Vertigo
10%
Palpitations
8%
Respiratory tract infection
6%
Depression
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
6%
Presyncope
6%
Pulmonary hypertension
4%
Anaemia
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
2%
Nausea
2%
Cardiac failure
2%
Cough
2%
Acute coronary syndrome
2%
Hypoxia
2%
Cardiovascular disorder
2%
Haemoglobin decreased
2%
Death
2%
Skin ulcer
2%
Back pain
2%
Haemoptysis
2%
Chest discomfort
2%
Walking distance test abnormal
2%
Coronary artery disease
2%
Pancreatic neoplasm
2%
Breast cancer
2%
Uterine haemorrhage
2%
Mitral valve incompetence
2%
Inguinal hernia
2%
Circulatory collapse
2%
General physical health deterioration
2%
Urinary tract infection
2%
Asthenia
2%
Respiratory syncytial virus infection
2%
Gangrene
2%
Sinusitis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil

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
215 Previous Clinical Trials
85,370 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,934 Previous Clinical Trials
47,791,956 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
~30 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top