Clinical trial

The Vascular Effects of Endothelin Receptor Antagonism in Systemic Vasculitis

Name
Bean ICRF clinical study
Description
Patients with vasculitis commonly develop cardiovascular disease. The reasons for this are not clear and is not adequately treated with current drugs. It is thus understand the reasons why patients with vasculitis develop cardiovascular disease in order to develop new drugs to reduced this risk. Endothelin is a chemical produced by blood vessels that contributes to the development of hypertension and cardiovascular disease Higher than normal levels of endothelin are seen in patients with vasculitis but how this contributes to cardiovascular disease in patients with vasculitis is not clear. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') the investigators can hopefully reduce the risk of cardiovascular disease in patients with vasculitis. The purpose of the study is to ascertain if endothelin receptor antagonists improve blood vessel function in patients with vasculitis.
Trial arms
Trial start
2016-08-01
Estimated PCD
2020-01-01
Trial end
2020-01-01
Status
Completed
Treatment
BQ123
Intravenous infusion of BQ123 ( selective ETA antagonist )
Arms:
BQ123
Other names:
Selective ETA antagonism
BQ123/788
or BQ123/788 (mixed ETA/B antagonists)
Arms:
BQ123/788
Other names:
mixed ETA/B antagonism
Placebo
Intravenous infusion of saline
Arms:
Placebo
Other names:
Saline
Size
64
Primary endpoint
Study 1 - forearm blood flow
20mins
Study 2 - pulse wave velocity
4 hours
Eligibility criteria
Inclusion Criteria: * Male or female * Age 18 years and over * Body mass index ≤35 * Normal serum albumin Exclusion Criteria: * Subject with diabetes or current smoking or chronic kidney disease (eGFR \<60ml/min) * Subject with pre-existing cardiovascular disease * Subject is below the age of legal consent, or is mentally or legally incapacitated * History of multiple and/or severe allergic reactions to drugs (including study drugs) * The subject has donated blood (450 ml) within the last 4 weeks * Past or present drug or alcohol abuse including intravenous drug abuse at any time * Participation in another clinical trial within 1 month * Considered to be at high risk of HIV or hepatitis B * Women of child-bearing potential (only women who are post-menopausal or surgically-sterilised will be included in the study)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}
Updated at
2023-11-29

1 organization

3 products

1 indication

Product
BQ123
Indication
Vasculitis
Product
BQ123/788
Product
Placebo