What side effects are associated with this type of intervention?

Common treatments for high blood pressure include thiazide diuretics, ACE inhibitors, ARBs, and calcium channel blockers. Thiazide diuretics can cause electrolyte imbalances, such as hyponatremia and hypokalemia, as well as hyperuricemia and gout. ACE inhibitors may lead to a persistent dry cough, elevated blood potassium levels, and, rarely, angioedema. ARBs are generally well-tolerated but can also cause elevated blood potassium levels and, less commonly, dizziness. Calcium channel blockers can result in side effects like peripheral edema, constipation, and dizziness. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate any adverse effects effectively.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of hypertension, including thiazide diuretics (e.g., hydrochlorothiazide), ACE inhibitors (e.g., enalapril, lisinopril), angiotensin II receptor blockers (ARBs) (e.g., losartan, valsartan), and long-acting dihydropyridine calcium channel blockers (e.g., amlodipine). These medications are often used in combination to achieve optimal blood pressure control. The trial for XXB750, a potential antihypertensive agent, builds on this foundation by exploring its efficacy, safety, and tolerability in patients with resistant hypertension.

What other types of research exist?

Promising novel alternatives to XXB750 for hypertension treatment include LCZ696 (sacubitril-valsartan), which has shown superior efficacy in reducing blood pressure compared to olmesartan. Additionally, omapatrilat has been reported with the latest clinical findings indicating its potential in treating hypertension.

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Other

XXB750 for Resistant Hypertension

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 specific antihypertensive medications

Apparent rHTN at screening (Visit 1) defined as uncontrolled BP with an office msSBP ≥ 140 mmHg despite treatment with stable, optimal or maximally tolerated doses of three or four antihypertensive drugs of different classes, including specific medications

Must not have

Receiving more than 4 antihypertensive medications

Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥9%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 9 and week 12

Summary

This trial tests a new medication called XXB750 given as injections under the skin. It targets patients whose high blood pressure doesn't improve with standard treatments. The goal is to see if XXB750 can safely and effectively lower their blood pressure.

Who is the study for?

Adults with resistant hypertension, who have high blood pressure despite taking three or four different blood pressure medications, can join this study. They must have a stable treatment regimen and not be pregnant, nursing, or planning to become pregnant without effective contraception. Excluded are those with recent cardiovascular events, secondary hypertension, severe kidney issues, certain drug histories including abuse or investigational drugs use.

What is being tested?

The trial is testing the effectiveness of XXB750 in lowering blood pressure when injected under the skin compared to a placebo. It's for patients whose high blood pressure isn't controlled by standard medication combinations. The study lasts 20 weeks and includes people already on recommended antihypertensive therapy.

What are the potential side effects?

While specific side effects of XXB750 aren't listed here, common ones for subcutaneous injections may include pain at injection site, potential allergic reactions, and systemic effects like nausea or headache depending on how the drug works.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My average blood pressure is 135 mmHg or higher, despite taking the highest dose of blood pressure medication I can tolerate.

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My blood pressure is high despite taking three or four different blood pressure medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking more than 4 medications for high blood pressure.

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I have Type I diabetes or my Type II diabetes is not under control (HbA1c ≥9%).

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My kidney function is low, with a GFR under 30 mL/min.

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I have undergone a procedure to treat high blood pressure affecting my kidneys.

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I have liver disease.

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I have been hospitalized for severe high blood pressure crises.

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I am a woman who can have children and am not using strong birth control methods.

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I have high blood pressure due to another health condition.

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I do not have any other diseases that would limit my life to under 3 years.

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I have not had cancer in any part of my body in the last 3 years.

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I struggle to understand or follow instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 9 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 9 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 9 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in mean 24hr SBP at Week 12

Secondary study objectives

Average of changes from baseline in mean 24hr SBP at Week 9 and at week 12

The proportions of participants achieving blood pressure control defined as mean 24hr SBP <130 mmHg and mean 24hr DBP <80 mmHg at Week 12

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose 4Experimental Treatment1 Intervention

Highest dose

Group II: Dose 3Experimental Treatment1 Intervention

Dose 3

Group III: Dose 2Experimental Treatment1 Intervention

Dose 2

Group IV: Dose 1Experimental Treatment1 Intervention

Lowest dose

Group V: Dose 5Placebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Experimental drug

2019

Completed Phase 2

~240

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include thiazide diuretics, ACE inhibitors, ARBs, and calcium channel blockers. Thiazide diuretics help reduce blood pressure by removing excess sodium and water from the body, decreasing blood volume. ACE inhibitors and ARBs both target the renin-angiotensin-aldosterone system (RAAS); ACE inhibitors block the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, while ARBs block the receptors for angiotensin II, preventing its action. Calcium channel blockers prevent calcium from entering the cells of the heart and blood vessel walls, leading to relaxed blood vessels and lower blood pressure. These mechanisms are crucial for hypertension patients as they help manage blood pressure levels, reducing the risk of cardiovascular events such as stroke and heart attack.

[120 mmHg for everyone?].Recent hypertension trials: implications and controversies.