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Clinical trial

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients

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Last updated:12th Sep 2023
Identifier: NCT05562934
An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients ID: NCT05562934

Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis (Novartis Pharmaceuticals) (Responsible Party)
Last Update Posted: 2023-09-13

Brief Summary:
The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC) injections, compared to placebo. Since all study participants will be patients with rHTN, all study treatments will be given on top of maximally tolerated background antihypertensive therapy recommended by international guidelines for treatment of HTN (i.e., a thiazide or a thiazide-like diuretic, an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), and a long-acting dihydropyridine calcium channel blocker (CCB).

Detailed Description:
Subjects will enter run-in period which lasts for approximately 2 weeks. The study duration is for 20 weeks during which each participant will receive a total of 3 doses of study medication (in addition to 1 dose of study medication during run-in). Participants will be followed to monitor their safety for an additional 8 weeks during which time no active study medication will be given.

Official 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

Intervention / Treatment:
- Biological: Experimental drug
- Other: Placebo

Category Value
Study Start (Actual) 2022-11-08
Primary Completion (Estimated) 2024-02-12
Study Completion (Estimated) 2024-03-12
Enrollment (Estimated) 170
Study Type Interventional
Phase Phase 2
Other Study ID Numbers

2021-005738-41 (EudraCT Number)

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