TRANSPARENT
Research type
Research Study
Full title
Zibotentan and Dapagliflozin in hypertensive patients- a pilot randomised controlled crossover clinical trial
IRAS ID
1010110
Contact name
Joseph Cheriyan
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN10215858
Research summary
High blood pressure, also known as hypertension, is a common condition and can increase the risk of heart attacks and strokes. Despite the availability of various medications, many people still have trouble keeping their blood pressure under control. Research suggests that about one-third of these patients do not reach their target blood pressure levels, even when taking medication.
This Phase 2 study aims to find out if two medications, Zibotentan and Dapagliflozin, can effectively lower blood pressure in
people with hypertension. Zibotentan blocks a protein called endothelin, which relaxes blood vessels and lowers blood pressure, but it can also cause the body to retain too much fluid. Dapagliflozin, a drug used to treat diabetes and heart failure, helps the kidneys remove sugar and water, which may reduce fluid build-up caused by Zibotentan.
Around 16 people with high blood pressure who are already taking at least two blood pressure medications will take part in this study at Cambridge University Hospital NHS Foundation Trust. This is a randomised, placebo-controlled, double-blind, crossover study, meaning participants will receive both the actual medication combination and a placebo at different times during the study. They will be randomly assigned to either start with the actual medication and then switch to the placebo, or start with the placebo and then switch to the actual medication. Participants will make 9 visits to the research site over about 18 weeks for blood pressure checks, blood tests, and monitoring for side effects.
The goal of this study is to determine if the combination of Zibotentan and Dapagliflozin can safely and effectively lower blood pressure.REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0051
Date of REC Opinion
14 Aug 2025
REC opinion
Further Information Favourable Opinion