The TARGET BP I Trial
Research type
Research Study
Full title
A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension
IRAS ID
264253
Contact name
Melvin Lobo
Contact email
Eudract number
2016-002545-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This is a Phase 3, multicenter, blinded, sham procedure-controlled trial of renal denervation by the Peregrine System Kit in subjects with Hypertension. The main purpose of the trial is to assess the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine system kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications.
The investigational product is a co-packaged combination product, the Peregrine System™ Kit. This contains a device component, the Peregrine System™ Infusion Catheter, and a drug component, Dehydrated Alcohol Injection, USP.
This is a RCT cohort which will randomize 150 patients in EU and 150 in USA; followed by a Safety cohort, in which also 150 patients will be treated in EU and the USA approximately.
The trial will include approximately 70 sites in Europe and US.
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1253
Date of REC Opinion
6 Nov 2019
REC opinion
Further Information Favourable Opinion