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XXB750 for Resistant Hypertension

Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female participants who are ≥ 18 years old
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 9 and week 12
Awards & highlights

Study Summary

This trial tests different doses of a new drug for resistant hypertension. It compares them to a placebo and evaluates safety, effectiveness and how well it's tolerated.

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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
My average blood pressure is 135 mmHg or higher, despite taking the highest dose of blood pressure medication I can tolerate.
Select...
My blood pressure is high despite taking three or four different blood pressure medications.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Average of changes from baseline in mean 24hr SBP at Week 9 and at week 12
Change from baseline in mean 24hr SBP 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 1
~50

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,852 Previous Clinical Trials
4,197,575 Total Patients Enrolled
1 Trials studying High Blood Pressure (Hypertension)
48 Patients Enrolled for High Blood Pressure (Hypertension)

Media Library

Experimental drug (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05562934 — Phase 2
High Blood Pressure (Hypertension) Research Study Groups: Dose 4, Dose 1, Dose 5, Dose 2, Dose 3
High Blood Pressure (Hypertension) Clinical Trial 2023: Experimental drug Highlights & Side Effects. Trial Name: NCT05562934 — Phase 2
Experimental drug (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05562934 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What security measures have been implemented to ensure the safety of participants receiving Dose 3?

"Our analysts have evaluated the safety of Dose 3 as a 2, since it is in Phase 2 trials and has evidence for its security but not its effectiveness."

Answered by AI

Are there any openings to join the trial at this time?

"Affirmative, according to clinicaltrials.gov the trial is presently recruiting patients; with its initial posting date on November 8th 2022 and last edited two weeks later. An estimated 170 participants are sought from 3 distinct medical sites."

Answered by AI

What is the size of the patient population involved in this clinical investigation?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical investigation, which was inaugurated on November 8th 2022, is seeking patient participation. Approximately 170 individuals need to be enlisted from 3 separate research centres."

Answered by AI

Who else is applying?

What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

How soon can we get started?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Because I'm not even 40 years old and if I don't find a solution I will die soon.
PatientReceived 1 prior treatment
~40 spots leftby Sep 2024