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Endothelin Receptor Antagonist

bosentan for Pulmonary Hypertension

Phase 3
Waitlist Available
Led By Christine Bradley
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

The primary objectives of this exploratory study are to evaluate the effects of bosentan on hemodynamics (via cardiac catheterization) during exercise in patients with Pulmonary Arterial Hypertension (PAH) who have abnormal hemodynamics during exercise but normal hemodynamics at rest. The authors hypothesize that early treatment may change the course of disease progression by improving hemodynamics during exercise, thus delaying disease progression.

Eligible Conditions
  • Pulmonary Hypertension
  • Connective Tissue Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The is the change in the following hemodynamics during exercise: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output∕cardiac input (CO∕CI), mean right arterial pressure (mRAP)
Secondary outcome measures
Change in hemodynamics at rest: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output/cardiac input (CO∕CI), mean right arterial pressure (mRAP)

Side effects data

From 2013 Phase 4 trial • 334 Patients • NCT00303459
19%
OEDEMA PERIPHERAL
16%
PULMONARY ARTERIAL HYPERTENSION
15%
HEADACHE
14%
COUGH
13%
UPPER RESPIRATORY TRACT INFECTION
13%
DYSPNOEA
12%
DIARRHOEA
11%
DIZZINESS
11%
CHEST PAIN
10%
NAUSEA
10%
ALANINE AMINOTRANSFERASE INCREASED
10%
URINARY TRACT INFECTION
9%
ANAEMIA
9%
BACK PAIN
9%
BRONCHITIS
8%
ARTHRALGIA
8%
ASPARTATE AMINOTRANSFERASE INCREASED
8%
EPISTAXIS
8%
FATIGUE
7%
PNEUMONIA
7%
LIVER FUNCTION TEST ABNORMAL
7%
ABDOMINAL PAIN
7%
NASOPHARYNGITIS
7%
SINUSITIS
6%
PAIN IN EXTREMITY
6%
RASH
6%
HEPATIC ENZYME INCREASED
6%
ANXIETY
5%
INSOMNIA
5%
MUSCLE SPASMS
5%
FALL
5%
NASAL CONGESTION
5%
VOMITING
4%
RIGHT VENTRICULAR FAILURE
4%
RESPIRATORY FAILURE
3%
ACUTE RESPIRATORY FAILURE
3%
ATRIAL FIBRILLATION
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
2%
FLUID OVERLOAD
2%
DEHYDRATION
2%
PULMONARY EMBOLISM
2%
HYPOXIA
2%
CELLULITIS
2%
SYNCOPE
2%
GASTROENTERITIS
1%
PULMONARY OEDEMA
1%
HYPERTENSION
1%
PLEURISY
1%
BRADYCARDIA
1%
RETINAL DETACHMENT
1%
CARDIAC FAILURE CONGESTIVE
1%
VASCULAR RESISTANCE PULMONARY INCREASED
1%
POSTOPERATIVE WOUND INFECTION
1%
ABDOMINAL ABSCESS
1%
ASCITES
1%
SPLENOMEGALY
1%
ABDOMINAL PAIN UPPER
1%
COR PULMONALE
1%
ATRIAL FLUTTER
1%
UTERINE LEIOMYOMA
1%
LOWER RESPIRATORY TRACT INFECTION
1%
GENERAL PHYSICAL HEALTH DETERIORATION
1%
SUPRAVENTRICULAR TACHYCARDIA
1%
FOOT FRACTURE
1%
BIPOLAR I DISORDER
1%
HUMERUS FRACTURE
1%
BRONCHOPNEUMONIA
1%
HIP FRACTURE
1%
POST PROCEDURAL COMPLICATION
1%
BRONCHIOLOALVEOLAR CARCINOMA
1%
MENORRHAGIA
1%
PNEUMOTHORAX
1%
SUICIDE ATTEMPT
1%
GASTROINTESTINAL DISORDER
1%
TRIFASCICULAR BLOCK
1%
DRUG HYPERSENSITIVITY
1%
EXTREMITY NECROSIS
1%
OBLITERATIVE BRONCHIOLITIS
1%
DIVERTICULITIS
1%
INTERVERTEBRAL DISC PROTRUSION
1%
HAEMATOCHEZIA
1%
HEPATIC CIRRHOSIS
1%
GASTROENTERITIS SALMONELLA
1%
PANCREATITIS
1%
ACUTE PULMONARY OEDEMA
1%
SEPTIC SHOCK
1%
CHRONIC RESPIRATORY FAILURE
1%
CARDIAC FAILURE
1%
SEPSIS
1%
CLOSTRIDIUM DIFFICILE COLITIS
1%
MYOCARDIAL INFARCTION
1%
BRONCHIAL HYPERREACTIVITY
1%
PNEUMONIA STAPHYLOCOCCAL
1%
SKIN ULCER
1%
LUNG INFECTION
1%
APPENDICITIS
1%
CORONARY ARTERY DISEASE
1%
GASTROOESOPHAGEAL REFLUX DISEASE
1%
ASTHMA
1%
ACUTE RIGHT VENTRICULAR FAILURE
1%
GASTROINTESTINAL HAEMORRHAGE
1%
HAEMATOMA INFECTION
1%
HAEMOPTYSIS
1%
PYELONEPHRITIS
1%
DENGUE FEVER
1%
CLOSTRIDIUM DIFFICILE INFECTION
1%
DEVICE RELATED SEPSIS
1%
ACUTE MYOCARDIAL INFARCTION
1%
SMALL INTESTINAL OBSTRUCTION
1%
SUDDEN DEATH
1%
HYPERKALAEMIA
1%
DYSPHAGIA
1%
RECTAL HAEMORRHAGE
1%
TRANSFUSION-RELATED ACUTE LUNG INJURY
1%
HYPOKALAEMIA
1%
RENAL HAEMATOMA
1%
FINGER AMPUTATION
1%
SCIATICA
1%
DIURETIC THERAPY
1%
DIFFUSE LARGE B-CELL LYMPHOMA
1%
INCISIONAL HERNIA REPAIR
1%
ELECTROCARDIOGRAM QT PROLONGED
1%
CORONARY ARTERY BYPASS
1%
LACERATION
1%
RIB FRACTURE
1%
ANAEMIA HAEMOLYTIC AUTOIMMUNE
1%
TRANSIENT ISCHAEMIC ATTACK
1%
NEUROPATHY PERIPHERAL
1%
RENAL FAILURE ACUTE
1%
MENTAL STATUS CHANGES
1%
UTERINE HAEMORRHAGE
1%
PNEUMOCOCCAL SEPSIS
1%
HYPERVOLAEMIA
1%
DEPRESSION
1%
UPPER GASTROINTESTINAL HAEMORRHAGE
1%
FLUID RETENTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bosentan
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: bosentanExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bosentan
FDA approved

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,991 Total Patients Enrolled
ActelionIndustry Sponsor
191 Previous Clinical Trials
35,683 Total Patients Enrolled
Christine BradleyPrincipal InvestigatorHamilton Health Sciences Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
2009. "A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00864201.
All > Pulmonary Arterial Hypertension > High Blood Pressure
~1 spots leftby May 2025
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