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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

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 ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
377 Previous Clinical Trials
340,390 Total Patients Enrolled
ActelionIndustry Sponsor
191 Previous Clinical Trials
35,519 Total Patients Enrolled
Christine BradleyPrincipal InvestigatorHamilton Health Sciences Corporation
~1 spots leftby Nov 2025
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