Pulmonary Arterial Hypertension Clinical Trial
Official title:
Characterisation of the Role of ETA and ETB Receptors in Regulating Plasma ET-1 and the Vasodilator Response to ET-3 in Man
Verified date | July 2015 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
Endothelin-1 (ET-1) has been linked to a number of conditions including pulmonary arterial
hypertension (PAH). ET-1 acts via 2 receptors, ETA and ETB. The ET-1 receptor blockers
bosentan and sitaxsentan have been shown to be beneficial in patients with PAH. Bosentan
blocks both ETA and ETB receptors. Sitaxsentan selectively blocks ETA receptors.
Theoretically, selective ETA blockade may be associated with greater vasodilation and
clearance of ET-1 by leaving the ETB receptor unblocked. This has not been directly studied
in humans.
We aim to investigate the endothelial ETB-mediated vascular responses between bosentan and
sitaxsentan by using a ETB selective agonist (ET-3). We hypothesise that at clinically
relevant doses:
- Bosentan will show evidence of ETB receptor blockade compared to sitaxsentan and
placebo.
- These effects will be confirmed by 2 functional markers of ETB receptor antagonism:
plasma ET-1 (a very sensitive, but not necessarily clinically relevant marker), and the
forearm vasodilator response to ET-3.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 2010 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Healthy men and post-menopausal women - Age 18-70 years - BMI 18-35 kg/m2 Exclusion Criteria: - Are mentally or legally incapacitated - Have donated blood within the last 4 weeks - Have a history of past or present drug or alcohol abuse - Have participated in another clinical trial within 1 month - Are considered to be at a high risk of HIV or Hepatitis B - Are taking routine medicines - Are women taking hormone replacement therapy - Have significant medical or psychiatric illness |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical Research Centre, Western General Hospital | Edinburgh | Scotland |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | Encysive Pharmaceuticals |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma ET-1 after 7-day administration of bosentan, sitaxsentan and placebo | 7 days | No | |
Primary | Responses to ET-3 (maximum vasodilation after ET-3 administration and area under the curve of vasodilation) after bosentan compared with the results from sitaxsentan and placebo. | 60 mins | No |
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