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

April 24, 2024 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Recruiting
        • Novartis Investigative Site
    • Queensland
      • Chemside, Queensland, Australia, 4032
        • Recruiting
        • Novartis Investigative Site
      • Milton, Queensland, Australia, 4064
        • Withdrawn
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Novartis Investigative Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Novartis Investigative Site
  • Austria
      • Braunau, Austria, A5280
        • Withdrawn
        • Novartis Investigative Site
      • Feldkirch, Austria, A 6807
        • Withdrawn
        • Novartis Investigative Site
      • Graz, Austria, A-8036
        • Completed
        • Novartis Investigative Site
      • Wien, Austria, 1190
        • Active, not recruiting
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1202
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1233
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1709
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 101200
        • Active, not recruiting
        • Novartis Investigative Site
      • Qingdao, China, 266000
        • Active, not recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Active, not recruiting
        • Novartis Investigative Site
      • Tianjin, China, 300140
        • Withdrawn
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 51000
        • Recruiting
        • Novartis Investigative Site
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Completed
        • Novartis Investigative Site
    • Jiangsu
      • Suzhou, Jiangsu, China, 215008
        • Withdrawn
        • Novartis Investigative Site
      • Xuzhou, Jiangsu, China, 221003
        • Withdrawn
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, China, 710061
        • Withdrawn
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Withdrawn
        • Novartis Investigative Site
    • Tianjin
      • Tianjin, Tianjin, China, 300121
        • Withdrawn
        • Novartis Investigative Site
  • Czechia
      • Praha, Czechia, 12808
        • Withdrawn
        • Novartis Investigative Site
      • Uherske Hradiste, Czechia, 68601
        • Withdrawn
        • Novartis Investigative Site
    • CZE
      • Praha 2, CZE, Czechia, 128 08
        • Recruiting
        • Novartis Investigative Site
    • Czech Republic
      • Brandys nad Labem, Czech Republic, Czechia, 250 01
        • Recruiting
        • Novartis Investigative Site
  • France
      • Bordeaux Cedex, France, 33075
        • Withdrawn
        • Novartis Investigative Site
      • Lille, France, 59037
        • Active, not recruiting
        • Novartis Investigative Site
      • Paris, France, 75015
        • Active, not recruiting
        • Novartis Investigative Site
      • Paris, France, 75018
        • Active, not recruiting
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Active, not recruiting
        • Novartis Investigative Site
      • Saint-Malo, France, 35400
        • Withdrawn
        • Novartis Investigative Site
      • Tours, France, 37000
        • Recruiting
        • Novartis Investigative Site
    • Rhone
      • Lyon cedex 04, Rhone, France, 69317
        • Withdrawn
        • Novartis Investigative Site
    • Seine Saint Denis
      • Bobigny cedex, Seine Saint Denis, France, 93009
        • Active, not recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Withdrawn
        • Novartis Investigative Site
      • Berlin, Germany, 10787
        • Completed
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Withdrawn
        • Novartis Investigative Site
      • Elsterwerda, Germany, 04910
        • Active, not recruiting
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Active, not recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45355
        • Withdrawn
        • Novartis Investigative Site
      • Frankfurt, Germany, 60594
        • Active, not recruiting
        • Novartis Investigative Site
      • Herne, Germany, 44625
        • Active, not recruiting
        • Novartis Investigative Site
      • Homburg, Germany, 66421
        • Withdrawn
        • Novartis Investigative Site
      • Ulm, Germany, 89077
        • Completed
        • Novartis Investigative Site
  • Italy
      • Bologna, Italy, 40100
        • Completed
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Active, not recruiting
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20122
        • Active, not recruiting
        • Novartis Investigative Site
      • Milano, MI, Italy, 20162
        • Active, not recruiting
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56126
        • Active, not recruiting
        • Novartis Investigative Site
  • Japan
    • Fukuka
      • Chikushino-city, Fukuka, Japan, 818-8516
        • Active, not recruiting
        • Novartis Investigative Site
    • Hiroshima
      • Kure-city, Hiroshima, Japan, 737-0023
        • Withdrawn
        • Novartis Investigative Site
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan, 300-8585
        • Withdrawn
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920 8650
        • Completed
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama city, Kanagawa, Japan, 232 0024
        • Active, not recruiting
        • Novartis Investigative Site
      • Yokosuka, Kanagawa, Japan, 238-8567
        • Active, not recruiting
        • Novartis Investigative Site
    • Osaka
      • Kishiwada-city, Osaka, Japan, 596-0042
        • Active, not recruiting
        • Novartis Investigative Site
    • Tokyo
      • Chuo ku, Tokyo, Japan, 104-0031
        • Completed
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Completed
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Completed
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Completed
        • Novartis Investigative Site
  • Poland
      • Gdynia, Poland, 81-157
        • Recruiting
        • Novartis Investigative Site
      • Grodzisk Mazowiecki, Poland, 05-825
        • Recruiting
        • Novartis Investigative Site
      • Katowice, Poland, 40-648
        • Recruiting
        • Novartis Investigative Site
      • Krakow, Poland, 30-002
        • Recruiting
        • Novartis Investigative Site
      • Lodz, Poland, 91-363
        • Recruiting
        • Novartis Investigative Site
      • Rzeszow, Poland, 35 055
        • Recruiting
        • Novartis Investigative Site
      • Warszawa, Poland, 00-215
        • Recruiting
        • Novartis Investigative Site
      • Wroclaw, Poland, 52-416
        • Recruiting
        • Novartis Investigative Site
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Recruiting
        • Novartis Investigative Site
      • Kosice, Slovakia, 040 01
        • Recruiting
        • Novartis Investigative Site
      • Lucenec, Slovakia, 98439
        • Recruiting
        • Novartis Investigative Site
      • Nitra, Slovakia, 949 01
        • Recruiting
        • Novartis Investigative Site
      • Presov, Slovakia, 080 01
        • Recruiting
        • Novartis Investigative Site
      • Svidnik, Slovakia, 089 01
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08025
        • Completed
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Active, not recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Withdrawn
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41014
        • Completed
        • Novartis Investigative Site
    • Barcelona
      • Sant Adria Del Besos, Barcelona, Spain, 08930
        • Withdrawn
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Recruiting
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08035
        • Active, not recruiting
        • Novartis Investigative Site
      • Terrassa, Catalunya, Spain, 08221
        • Active, not recruiting
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Recruiting
        • Novartis Investigative Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Active, not recruiting
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 110
        • Active, not recruiting
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Active, not recruiting
        • Novartis Investigative Site
      • London, United Kingdom, W1T 7HA
        • Active, not recruiting
        • Novartis Investigative Site
      • Salford, United Kingdom, M6 8HD
        • Active, not recruiting
        • Novartis Investigative Site
    • GBR
      • London, GBR, United Kingdom, EC1M 6BQ
        • Active, not recruiting
        • Novartis Investigative Site
    • Northern Ireland
      • Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
        • Withdrawn
        • Novartis Investigative Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Active, not recruiting
        • Pinnacle Research Group LLC .
      • Birmingham, Alabama, United States, 35206
        • Recruiting
        • Parkway Medical Center Research Department
        • Principal Investigator:
          • James Sullivan
      • Guntersville, Alabama, United States, 35976
        • Withdrawn
        • Lakeview Clinical Research LLC
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • National Heart Institute
        • Principal Investigator:
          • Norman Lepor
        • Contact:
          • Phone Number: 301-289-5221
      • Sacramento, California, United States, 95821-2134
        • Active, not recruiting
        • Clinical Trials Research Sacramento
      • San Dimas, California, United States, 91773
        • Recruiting
        • North America Research Institute
        • Principal Investigator:
          • Aamir Jamal
        • Contact:
      • Tustin, California, United States, 92780
        • Active, not recruiting
        • Orange County Research Center Research
    • Florida
      • Crystal River, Florida, United States, 34429
        • Withdrawn
        • Nature Coast Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Active, not recruiting
        • Jacksonville Ctr for Clin Rea Main Centre
      • Lake Worth, Florida, United States, 33467
        • Recruiting
        • Canvas Clinical Research
        • Contact:
        • Principal Investigator:
          • Mario Guillen
      • Miami Lakes, Florida, United States, 33014
        • Active, not recruiting
        • Inpatient Research Clinical LLC
      • Ponte Vedra, Florida, United States, 32801
        • Recruiting
        • St Johns Center Research
        • Contact:
        • Principal Investigator:
          • Ameeth Vedre
      • Tampa, Florida, United States, 33614
        • Withdrawn
        • Genesis Clinical Research Research
      • Wellington, Florida, United States, 33449
    • Georgia
      • Acworth, Georgia, United States, 30101
        • Active, not recruiting
        • American Clinical Trials Nephrology
    • Idaho
      • Chubbuck, Idaho, United States, 83202
        • Withdrawn
        • CaRe Research Research
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Active, not recruiting
        • Alliance for Multispecialty Resrch Research
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Recruiting
        • Research Integrity LLC
        • Contact:
        • Principal Investigator:
          • David J Johnson
    • Maryland
      • Fort Washington, Maryland, United States, 20744
        • Recruiting
        • Anderson Medical Research
        • Principal Investigator:
          • Felton Anderson
        • Contact:
          • Phone Number: 301-542-6741
      • Lanham, Maryland, United States, 20706
        • Active, not recruiting
        • Capitol Cardiology Associates
      • Oxon Hill, Maryland, United States, 20745
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health Research
        • Principal Investigator:
          • David Lanfear
        • Contact:
      • Rochester, Michigan, United States, 48307
        • Withdrawn
        • Ascension Providence Rochester
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Withdrawn
        • Novartis Investigative Site
      • Southaven, Mississippi, United States, 38671
        • Withdrawn
        • Novartis Investigative Site
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Cardiology Assoc Research LLC
        • Principal Investigator:
          • Barry Bertolet
        • Contact:
    • Ohio
      • Lima, Ohio, United States, 45805
        • Active, not recruiting
        • NexGen Research
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • The Research Center of the Upstate
        • Principal Investigator:
          • Harlicia Farley
        • Contact:
          • Phone Number: 608-504-3779
      • Little River, South Carolina, United States, 29566
        • Recruiting
        • Main Street Physicians Care
        • Contact:
        • Principal Investigator:
          • Patrick Ryan
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Active, not recruiting
        • University of Tennessee Health Science Center .
      • Tullahoma, Tennessee, United States, 37388
        • Recruiting
        • Tennessee Center For Clinical Trials .
        • Contact:
        • Principal Investigator:
          • Dinesh Gupta
    • Texas
      • Dallas, Texas, United States, 75234
        • Recruiting
        • DFW Clinical Research LLC
        • Contact:
        • Principal Investigator:
          • Waymon Drummond
    • Virginia
      • Manassas, Virginia, United States, 20109
        • Withdrawn
        • Carient Heart and Vascular
      • Manassas, Virginia, United States, 20110
        • Active, not recruiting
        • Manassas Clinical Research Center .
      • Norfolk, Virginia, United States, 23504
      • Richmond, Virginia, United States, 23219
        • Active, not recruiting
        • Dominion Medical Associates .

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female participants who are ≥ 18 years old.
  2. Signed informed consent prior to participation in the study.
  3. Apparent rHTN at screening (Visit 1) defined as uncontrolled BP with an office msSBP ≥ 140 mmHg despite treatment with stable (i.e., unchanged for ≥4 weeks), optimal or maximally tolerated doses of three or four antihypertensive drugs of different classes, including an ACEI/ARB, a long-acting dihydropyridine CCB, and a thiazide or thiazide-like diuretic. Participant with documented intolerance to any doses of CCBs may be eligible if receiving another class of antihypertensive medication at an optimal or maximally tolerated dose (referred to as triple background antihypertensive therapy. An optimal dose is defined as the highest dose taking in to account participant's documented comorbidities and tolerability per investigator's clinical judgment.
  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. Subjects with the following blood pressures at the specified time points are not eligible to participate in the study:

    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.
  9. Acute myocardial infarction (AMI) or unstable angina, or any history of ischemic or hemorrhagic stroke within 12 months of screening; or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 12 months of screening
  10. History of a renal denervation procedure.
  11. Mid-arm circumference ≥44 cm. The cuff should snugly fit on the arm with out the margins of cuff overhanging arm musculature.
  12. Patients with history of hospitalisation for hypertensive emergencies characterised by severe hypertension (usually grade 3) associated with funduscopic changes (flame haemorrhages and/or papilloedema), microangiopathy, disseminated intravascular coagulation, encephalopathy, acute aortic dissection, acute myocardial ischaemia, or acute heart failure any time prior to screening or hospitalisation for non-emergent/non-urgent uncontrolled hypertension without target organ damage within 3 months prior to screening
  13. Receiving more than 4 antihypertensive medications.
  14. Night shift workers.
  15. History of presence of any other disease where the life expectancy is less than 3 years.
  16. History of malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin or localized prostate cancer), treated or untreated, within the past 3 years, regardless of whether there is evidence of local recurrence or metastases.
  17. Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x the upper limit of normal (ULN), or bilirubin >1.5 mg/dl at Visit 1.
  18. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  19. History of drug abuse or alcohol dependency.
  20. Lacking the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, a participant that would be unlikely or unable to comply with study protocol.
  21. Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional registries is acceptable).
  22. Requiring prolonged/regular use of NSAIDs except for prophylactic use of low dose aspirin up to 325 mg QD or other prohibited medications during of the study (i.e., required use for longer than 1 week).

  23. Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required within a maximum of 7 days prior to enrollment of all women of childbearing potential). Documentation of highly effective contraception is also required for women of childbearing potential (see below).

    Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 months after stopping medication. Highly effective contraception methods include:

    • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
    • Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
    • Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.

    In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

    Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women are considered not of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential.

    If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.

  24. History of hypersensitivity to any of the study drugs, excipients or drugs of similar class.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 2
Biological: Experimental drug
SC injection
Experimental: Dose 3
Biological: Experimental drug
SC injection
Experimental: Dose 1
Lowest dose
Biological: Experimental drug
SC injection
Experimental: Dose 4
Highest dose
Biological: Experimental drug
SC injection
Placebo Comparator: Dose 5
Placebo
Other: Placebo
SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mean 24hr SBP at Week 12
Time Frame: 12 weeks
To evaluate the efficacy and dose-response relationship of different doses of XXB750 SC compared to placebo in reducing the mean 24hr ambulatory systolic blood pressure (mean 24hr SBP) from baseline at Week 12.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mean 24hr SBP at Week 12
Time Frame: 12 weeks
To evaluate the treatment effect of the highest XXB750 dose versus placebo in reducing the mean 24hr SBP from baseline to Week 12
12 weeks
The proportions of participants achieving blood pressure control defined as mean 24hr SBP <130 mmHg and mean 24hr DBP <80 mmHg at Week 12
Time Frame: 12 weeks
To evaluate the proportions of participants achieving ambulatory BP control (i.e., mean 24hr SBP < 130 mmHg and mean 24hr DBP < 80 mmHg) with respect to the dose-response relationship of the four XXB750 dose level groups compared to placebo at week 12.
12 weeks
Average of changes from baseline in mean 24hr SBP at Week 9 and at week 12
Time Frame: Baseline, week 9 and week 12
To evaluate the treatment effect of the highest XXB750 dose versus placebo in the dosing interval average of ambulatory SBP as assessed by average of mean 24hr SBP measured at week 9 and week 12
Baseline, week 9 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Estimated)

September 6, 2024

Study Completion (Estimated)

September 8, 2024

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXXB750B12201
  • 2021-005738-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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