*CXXB750B12201
Research type
Research Study
Full title
A multi-center, randomized, double-blind, parallel-group, 20-week dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with resistant hypertension
IRAS ID
1006411
Contact name
Laurie Heinrich
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-005738-41
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to help to understand how effective and how safe and tolerable different doses of XXB750 are in resistant hypertension patients. Subjects whose blood pressure is not under control despite treatment with triple antihypertensive medications, including an angiotensin converting enzyme blocker or angiotensin receptor blocker, a calcium channel blocker, and a thiazide or thiazide-like diuretic will be recruited into the study Subjects will receive a single-blind XXB750 placebo injection at the start of the run-in period which lasts for approximately 2 weeks. Subjects whose blood pressure is still not under control at the end of the run-in period despite compliance with triple antihypertensive background treatment will be randomized to receive one of four dose levels of XXB750 (30 mg, 60 mg, 120 mg, or 240 mg SC Q4W) or placebo Q4W. Overall, a total of approximately 170 participants will be randomized. The study duration is for 20 weeks (not including screening and run in period) during which each participant will receive a total of 3 doses of study medication at 4 weekly intervals, i.e., at baseline, 4 weeks, and 8 weeks. Ambulatory blood pressure monitoring will occur at baseline, Week 9, and Week 12 (primary endpoint timepoint). Office blood pressure will be measured at each office visit. Home blood pressure will be measured by the participants using provided devices on specified days throughout the study. Participants will be followed to monitor their safety for an additional 8 weeks during which time no active study medication will be given. Each of the first approximately 68 randomized participants will be assigned to receive one of the three lower doses of XXB750 or placebo.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0712
Date of REC Opinion
12 Dec 2022
REC opinion
Further Information Favourable Opinion