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An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT05562934•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female participants who are ≥ 18 years old.
•2. Signed informed consent prior to participation in the study.
•4. Mean 24hr SBP ≥135 mmHg (measured by ABPM) at the end-of Run-in-Visit (Visit 30) on treatment with optimal or maximally tolerated doses of an ACEI/ARB, a long-acting dihydropyridine CCB (or a suitable alternative in case of intolerance per inclusion criterion above), and a thiazide or thiazide-like diuretic.

Exclusion Criteria

•1. Office msSBP \<140 mmHg at Visit 20 OR
•2. Office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at the end-of-run-in visit (Visit 30) OR
•3. 24h mean SBP \>170 mmHg or 24h mean DBP \>105mmHg measured by ABPM at the end of the run-in (Visit 30).
•2. Known history of secondary hypertension (moderate-to-severe obstructive sleep apnea without receiving CPAP therapy (either face mask or nasal device), renovascular hypertension, primary aldosteronism, pheochromocytoma, Cushing syndrome, aortic coarctation or other cause of secondary hypertension).
•3. Estimated GFR \<30 mL/min/1.73m2 using CKD-Epi equation at screening (Visit 1) or at end-of-run-in visit (Visit 30).
•4. Serum potassium \>5.0 mmol/L (or equivalent plasma potassium value) at screening or end-of-run-in visit (Visit 30).
•5. Current therapy with a mineralocorticoid receptor antagonist (MRA) or sacubitril/valsartan or received an MRA or sacubitril/valsartan within the 4 weeks prior to screening.
•6. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥9%)
•7. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), high-grade AV block (e.g., Mobitz type II and third-degree AV block in absence of a pacemaker) within 6 months of screening according to investigator's judgement.
•8. Chronic non-paroxysmal atrial fibrillation.
+24 more criteria

Locations (78)

Pinnacle Research Group Llc

Anniston, Alabama, United States

Parkway Medical Center

Birmingham, Alabama, United States

Clinical Trials Research Sacramento

Sacramento, California, United States

Orange County Research Center

Tustin, California, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Canvas Clinical Research

Lake Worth, Florida, United States

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Cardiology Partners Clinical Research Institute

Wellington, Florida, United States

American Clinical Trials

Acworth, Georgia, United States

Alliance for Multispecialty Resrch

Wichita, Kansas, United States

Key Dates

Start Date

November 8, 2022

Primary Completion Date

July 2, 2024

Completion Date

August 27, 2024

Last Updated

January 12, 2026

Enrollment

189

ACTUAL participants

Conditions

Resistant Hypertension

Interventions

XXB750 drug

BIOLOGICAL

Placebo

OTHER

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Resistant Hypertension

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RECRUITING

Symplicity China Study

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RECRUITINGPHASE2

Endocalyx in Treatment Resistent Hypertension

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Treatment Resistant Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Endothelin-1 Receptor Blockade in Resistant Hypertension

Symplicity China Study

Endocalyx in Treatment Resistent Hypertension

Evaluation of Two Isometric Exercises in the Reduction of the Blood Pressure in People With Resistant Hypertension

Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM)

Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension