Dose 3 for High Blood Pressure (Hypertension)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
High Blood Pressure (Hypertension)Experimental drug - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions
  • High Blood Pressure (Hypertension)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 3 Secondary · Reporting Duration: 12 weeks

12 Weeks
Nocturnal SBP dipping expressed as (nighttime mean SBP/daytime mean SBP) at Week 12
12 weeks
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 Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

Dose 3
1 of 5
Dose 1
1 of 5
Dose 2
1 of 5
Dose 4
1 of 5
Dose 5
1 of 5

Experimental Treatment

Non-Treatment Group

170 Total Participants · 5 Treatment Groups

Primary Treatment: Dose 3 · Has Placebo Group · Phase 2

Dose 3
Biological
Experimental Group · 1 Intervention: Experimental drug · Intervention Types: Biological
Dose 1
Biological
Experimental Group · 1 Intervention: Experimental drug · Intervention Types: Biological
Dose 2
Biological
Experimental Group · 1 Intervention: Experimental drug · Intervention Types: Biological
Dose 4
Biological
Experimental Group · 1 Intervention: Experimental drug · Intervention Types: Biological
Dose 5
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental drug
2012
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,685 Total Patients Enrolled
1 Trials studying High Blood Pressure (Hypertension)
48 Patients Enrolled for High Blood Pressure (Hypertension)

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you: