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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT01100736 |
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Date of registration:
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30/03/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)
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Scientific title:
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Characterisation of the Role of ETA and ETB Receptors in Regulating Plasma ET-1 and the Vasodilator Response to ET-3 in Man |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01100736 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Phase:
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Phase 0
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Vasodilation
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Vasoconstriction
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Intervention(s)
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Biological: Endothelin-3
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Drug: Placebo
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Drug: Bosentan
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Drug: Sitaxsentan
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Primary Outcome(s)
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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.
[Time Frame: 60 mins]
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Plasma ET-1 after 7-day administration of bosentan, sitaxsentan and placebo
[Time Frame: 7 days]
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Secondary ID(s)
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2008/W/CRC/01
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08/S1102/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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