Phase
Condition
High Blood Pressure (Hypertension - Pediatric)
Stress
Diabetes And Hypertension
Treatment
Placebo
Experimental drug
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female participants who are ≥ 18 years old.
Signed informed consent prior to participation in the study.
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 ormaximally tolerated doses of three or four antihypertensive drugs of differentclasses, including an ACEI/ARB, a long-acting dihydropyridine CCB, and a thiazide orthiazide-like diuretic. Participant with documented intolerance to any doses of CCBsmay be eligible if receiving another class of antihypertensive medication at anoptimal or maximally tolerated dose (referred to as triple backgroundantihypertensive therapy. An optimal dose is defined as the highest dose taking into account participant's documented comorbidities and tolerability perinvestigator's clinical judgment.
Mean 24hr SBP ≥135 mmHg (measured by ABPM) at the end-of Run-in-Visit (Visit 30) ontreatment with optimal or maximally tolerated doses of an ACEI/ARB, a long-actingdihydropyridine CCB (or a suitable alternative in case of intolerance per inclusioncriterion above), and a thiazide or thiazide-like diuretic.
Exclusion
Exclusion Criteria:
Subjects with the following blood pressures at the specified time points are noteligible to participate in the study:
Office msSBP <140 mmHg at Visit 20 OR
Office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at the end-of-run-in visit (Visit 30) OR
24h mean SBP >170 mmHg or 24h mean DBP >105mmHg measured by ABPM at the end ofthe run-in (Visit 30).
Known history of secondary hypertension (moderate-to-severe obstructive sleep apneawithout receiving CPAP therapy (either face mask or nasal device), renovascularhypertension, primary aldosteronism, pheochromocytoma, Cushing syndrome, aorticcoarctation or other cause of secondary hypertension).
Estimated GFR <30 mL/min/1.73m2 using CKD-Epi equation at screening (Visit 1) or atend-of-run-in visit (Visit 30).
Serum potassium >5.0 mmol/L (or equivalent plasma potassium value) at screening orend-of-run-in visit (Visit 30).
Current therapy with a mineralocorticoid receptor antagonist (MRA) orsacubitril/valsartan or received an MRA or sacubitril/valsartan within the 4 weeksprior to screening.
Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥9%)
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 apacemaker) within 6 months of screening according to investigator's judgement.
Chronic non-paroxysmal atrial fibrillation.
Acute myocardial infarction (AMI) or unstable angina, or any history of ischemic orhemorrhagic stroke within 12 months of screening; or any percutaneous coronaryintervention (PCI) or coronary artery bypass graft (CABG) within 12 months ofscreening
History of a renal denervation procedure.
Mid-arm circumference ≥44 cm. The cuff should snugly fit on the arm with out themargins of cuff overhanging arm musculature.
Patients with history of hospitalisation for hypertensive emergencies characterisedby severe hypertension (usually grade 3) associated with funduscopic changes (flamehaemorrhages and/or papilloedema), microangiopathy, disseminated intravascularcoagulation, encephalopathy, acute aortic dissection, acute myocardial ischaemia, oracute heart failure any time prior to screening or hospitalisation fornon-emergent/non-urgent uncontrolled hypertension without target organ damage within 3 months prior to screening
Receiving more than 4 antihypertensive medications.
Night shift workers.
History of presence of any other disease where the life expectancy is less than 3years.
History of malignancy of any organ system (other than localized basal or squamouscell carcinoma of the skin or localized prostate cancer), treated or untreated,within the past 3 years, regardless of whether there is evidence of local recurrenceor metastases.
Evidence of hepatic disease as determined by any one of the following: SGOT (AST) orSGPT (ALT) values exceeding 3x the upper limit of normal (ULN), or bilirubin >1.5mg/dl at Visit 1.
Use of other investigational drugs at the time of enrollment, or within 30 days or 5half-lives of enrollment, whichever is longer.
History of drug abuse or alcohol dependency.
Lacking the ability to comprehend or follow instructions, or for any reason in theopinion of the investigator, a participant that would be unlikely or unable tocomply with study protocol.
Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional registries is acceptable).
Requiring prolonged/regular use of NSAIDs except for prophylactic use of low doseaspirin up to 325 mg QD or other prohibited medications during of the study (i.e.,required use for longer than 1 week).
Pregnant, nursing or planning to become pregnant (documented negative pregnancy testrequired within a maximum of 7 days prior to enrollment of all women of childbearingpotential). Documentation of highly effective contraception is also required forwomen of childbearing potential (see below). Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionwhile taking study treatment and for 3 months after stopping medication. Highlyeffective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyleof the participant. Periodic abstinence (e.g. calendar, ovulation,symptom-thermal, post-ovulation methods) and withdrawal are not acceptablemethods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or withouthysterectomy), total hysterectomy, or bilateral tubal ligation at least sixweeks before taking study treatment. In case of oophorectomy alone, only whenthe reproductive status of the woman has been confirmed by follow-up hormonelevel assessment.
Male sterilization (at least 6 months prior to screening). For femaleparticipants on the study, the vasectomized male partner should be the solepartner for that participant.
Use of oral, (estrogen and progesterone), injected, or implanted hormonalmethods of contraception or placement of an intrauterine device (IUD) orintrauterine system (IUS), or other forms of hormonal contraception that havecomparable efficacy (failure rate < 1%), for example hormone vaginal ring ortransdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pillfor 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-appropriatehistory of vasomotor symptoms). Women are considered not of childbearing potentialif they are post-menopausal or have had surgical bilateral oophorectomy (with orwithout hysterectomy), total hysterectomy or bilateral tubal ligation at least sixweeks ago. In the case of oophorectomy alone, only when the reproductive status ofthe woman has been confirmed by follow-up hormone level assessment is she considerednot of child bearing potential. If local regulations deviate from the contraception methods listed above to preventpregnancy, local regulations apply and will be described in the ICF.
- History of hypersensitivity to any of the study drugs, excipients or drugs ofsimilar class.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Gosford, New South Wales 2250
AustraliaSite Not Available
Novartis Investigative Site
Chemside, Queensland 4032
AustraliaSite Not Available
Novartis Investigative Site
Milton, Queensland 4064
AustraliaSite Not Available
Novartis Investigative Site
Adelaide, South Australia 5000
AustraliaSite Not Available
Novartis Investigative Site
Perth, Western Australia 6000
AustraliaSite Not Available
Novartis Investigative Site
Braunau, A5280
AustriaSite Not Available
Novartis Investigative Site
Feldkirch, A 6807
AustriaSite Not Available
Novartis Investigative Site
Graz, 8036
AustriaSite Not Available
Novartis Investigative Site
Wien, 1190
AustriaSite Not Available
Novartis Investigative Site
Pleven, 5800
BulgariaSite Not Available
Novartis Investigative Site
Plovdiv, 4002
BulgariaSite Not Available
Novartis Investigative Site
Sofia, 1233
BulgariaSite Not Available
Novartis Investigative Site
Guangzhou, Guangdong 510080
ChinaSite Not Available
Novartis Investigative Site
Baotou, Inner Mongolia 014010
ChinaSite Not Available
Novartis Investigative Site
Suzhou, Jiangsu 215008
ChinaSite Not Available
Novartis Investigative Site
Xuzhou, Jiangsu 221003
ChinaSite Not Available
Novartis Investigative Site
Xian, Shanxi 710061
ChinaSite Not Available
Novartis Investigative Site
Chengdu, Sichuan 610072
ChinaSite Not Available
Novartis Investigative Site
Beijing, 101200
ChinaSite Not Available
Novartis Investigative Site
Qingdao, 266000
ChinaSite Not Available
Novartis Investigative Site
Shanghai, 200025
ChinaSite Not Available
Novartis Investigative Site
Tianjin, 300140
ChinaSite Not Available
Novartis Investigative Site
Praha 2, CZE 128 08
CzechiaSite Not Available
Novartis Investigative Site
Brandys nad Labem, Czech Republic 250 01
CzechiaSite Not Available
Novartis Investigative Site
Praha, 12808
CzechiaSite Not Available
Novartis Investigative Site
Uherske Hradiste, 68601
CzechiaSite Not Available
Novartis Investigative Site
Lyon cedex 04, Rhone 69317
FranceSite Not Available
Novartis Investigative Site
Bobigny cedex, Seine Saint Denis 93009
FranceSite Not Available
Novartis Investigative Site
Bobigny Cedex, 93009
FranceSite Not Available
Novartis Investigative Site
Bordeaux Cedex, 33075
FranceSite Not Available
Novartis Investigative Site
Lille, 59000
FranceSite Not Available
Novartis Investigative Site
Lyon Cedex 04, 69317
FranceActive - Recruiting
Novartis Investigative Site
Paris, 75015
FranceSite Not Available
Novartis Investigative Site
Paris cedex 18, 75877
FranceSite Not Available
Novartis Investigative Site
Poitiers, 86021
FranceSite Not Available
Novartis Investigative Site
Saint-Malo, 35400
FranceSite Not Available
Novartis Investigative Site
Tours, 37044
FranceSite Not Available
Novartis Investigative Site
Berlin, 10787
GermanySite Not Available
Novartis Investigative Site
Dresden, 01307
GermanySite Not Available
Novartis Investigative Site
Elsterwerda, 04910
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91054
GermanySite Not Available
Novartis Investigative Site
Essen, 45355
GermanySite Not Available
Novartis Investigative Site
Frankfurt, 60594
GermanySite Not Available
Novartis Investigative Site
Herne, 44625
GermanySite Not Available
Novartis Investigative Site
Homburg, 66421
GermanySite Not Available
Novartis Investigative Site
Ulm, 89077
GermanySite Not Available
Novartis Investigative Site
Bologna, BO 40138
ItalySite Not Available
Novartis Investigative Site
Brescia, BS 25123
ItalySite Not Available
Novartis Investigative Site
Milano, MI 20122
ItalySite Not Available
Novartis Investigative Site
Pisa, PI 56124
ItalySite Not Available
Novartis Investigative Site
Chikushino-city, Fukuka 818-8516
JapanSite Not Available
Novartis Investigative Site
Kure-city, Hiroshima 737-0023
JapanSite Not Available
Novartis Investigative Site
Tsuchiura, Ibaraki 300-8585
JapanSite Not Available
Novartis Investigative Site
Kanazawa, Ishikawa 920 8650
JapanSite Not Available
Novartis Investigative Site
Yokohama city, Kanagawa 232 0024
JapanSite Not Available
Novartis Investigative Site
Yokosuka, Kanagawa 238-8567
JapanSite Not Available
Novartis Investigative Site
Kishiwada-city, Osaka 596-0042
JapanSite Not Available
Novartis Investigative Site
Chuo Ku, Tokyo 103-0027
JapanSite Not Available
Novartis Investigative Site
Chuo ku, Tokyo 104-0031
JapanSite Not Available
Novartis Investigative Site
Chuo-ku, Tokyo 103-0027
JapanSite Not Available
Novartis Investigative Site
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Novartis Investigative Site
Gdynia, 81-157
PolandSite Not Available
Novartis Investigative Site
Grodzisk Mazowiecki, 05-825
PolandSite Not Available
Novartis Investigative Site
Katowice, 40-648
PolandSite Not Available
Novartis Investigative Site
Krakow, 30-002
PolandSite Not Available
Novartis Investigative Site
Lodz, 91-363
PolandSite Not Available
Novartis Investigative Site
Rzeszow, 35 055
PolandSite Not Available
Novartis Investigative Site
Warszawa, 00-215
PolandSite Not Available
Novartis Investigative Site
Wroclaw, 52-416
PolandSite Not Available
Novartis Investigative Site
Bardejov, 085 01
SlovakiaSite Not Available
Novartis Investigative Site
Kosice, 040 01
SlovakiaSite Not Available
Novartis Investigative Site
Lucenec, 98439
SlovakiaSite Not Available
Novartis Investigative Site
Nitra, 949 01
SlovakiaSite Not Available
Novartis Investigative Site
Presov, 080 01
SlovakiaSite Not Available
Novartis Investigative Site
Svidnik, 089 01
SlovakiaSite Not Available
Novartis Investigative Site
Sevilla, Andalucia 41014
SpainSite Not Available
Novartis Investigative Site
Sant Adria Del Besos, Barcelona 08930
SpainSite Not Available
Novartis Investigative Site
Terrassa, Catalunya 08221
SpainSite Not Available
Novartis Investigative Site
Valencia, Comunidad Valenciana 46010
SpainSite Not Available
Novartis Investigative Site
Pamplona, Navarra 31008
SpainSite Not Available
Novartis Investigative Site
Barcelona, 08025
SpainSite Not Available
Novartis Investigative Site
Madrid, 28041
SpainSite Not Available
Novartis Investigative Site
Kaohsiung, 80756
TaiwanSite Not Available
Novartis Investigative Site
Taipei, 11217
TaiwanSite Not Available
Novartis Investigative Site
Taoyuan, 33305
TaiwanSite Not Available
Novartis Investigative Site
Craigavon, Northern Ireland BT63 5QQ
United KingdomSite Not Available
Novartis Investigative Site
Glasgow, G51 4TF
United KingdomSite Not Available
Novartis Investigative Site
London, W1T 7HA
United KingdomSite Not Available
Novartis Investigative Site
Salford, M6 8HD
United KingdomSite Not Available
Novartis Investigative Site
Anniston, Alabama 36207
United StatesActive - Recruiting
Pinnacle Research Group Llc
Anniston, Alabama 36207
United StatesSite Not Available
Pinnacle Research Group Llc .
Anniston, Alabama 36207
United StatesSite Not Available
Parkway Medical Center
Birmingham, Alabama 35206
United StatesSite Not Available
Parkway Medical Center Research Department
Birmingham, Alabama 35206
United StatesSite Not Available
Lakeview Clinical Research LLC
Guntersville, Alabama 35976
United StatesSite Not Available
Novartis Investigative Site
Guntersville, Alabama 35976
United StatesSite Not Available
National Heart Institute
Beverly Hills, California 90211
United StatesSite Not Available
Novartis Investigative Site
Beverly Hills, California 90211
United StatesActive - Recruiting
Clinical Trials Research Sacramento
Sacramento, California 95821-2134
United StatesSite Not Available
Novartis Investigative Site
Sacramento, California 95821-2134
United StatesActive - Recruiting
North America Research Institute
San Dimas, California 91773
United StatesSite Not Available
Novartis Investigative Site
San Dimas, California 91773
United StatesActive - Recruiting
Novartis Investigative Site
Tustin, California 92780
United StatesActive - Recruiting
Orange County Research Center
Tustin, California 92780
United StatesSite Not Available
Orange County Research Center Research
Tustin, California 92780
United StatesSite Not Available
Nature Coast Clinical Research
Crystal River, Florida 34429
United StatesSite Not Available
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United StatesSite Not Available
Jacksonville Center for Clinical Research Main Centre
Jacksonville, Florida 32216
United StatesSite Not Available
Jacksonville Ctr For Clin Rea Main Centre
Jacksonville, Florida 32216
United StatesSite Not Available
Novartis Investigative Site
Jacksonville, Florida 32216
United StatesActive - Recruiting
Canvas Clinical Research
Lake Worth, Florida 33467
United StatesSite Not Available
Novartis Investigative Site
Lake Worth, Florida 33467
United StatesActive - Recruiting
Inpatient Research Clinical LLC
Miami Lakes, Florida 33014
United StatesSite Not Available
Novartis Investigative Site
Ponte Vedra, Florida 32801
United StatesActive - Recruiting
St Johns Center Research
Ponte Vedra, Florida 32801
United StatesSite Not Available
Genesis Clinical Research Research
Tampa, Florida 33614
United StatesSite Not Available
Cardiology Partners Clinical Research Institute
Wellington, Florida 33449
United StatesSite Not Available
Novartis Investigative Site
Wellington, Florida 33449
United StatesActive - Recruiting
American Clinical Trials
Acworth, Georgia 30101
United StatesSite Not Available
American Clinical Trials Nephrology
Acworth, Georgia 30101
United StatesSite Not Available
Novartis Investigative Site
Acworth, Georgia 30101
United StatesActive - Recruiting
CaRe Research Research
Chubbuck, Idaho 83202
United StatesSite Not Available
Alliance for Multispecialty Resrch
Wichita, Kansas 67207
United StatesSite Not Available
Alliance for Multispecialty Resrch Research
Wichita, Kansas 67207
United StatesSite Not Available
Novartis Investigative Site
Owensboro, Kentucky 42303
United StatesActive - Recruiting
Research Integrity LLC
Owensboro, Kentucky 42303
United StatesSite Not Available
Anderson Medical Research
Fort Washington, Maryland 20744
United StatesSite Not Available
Novartis Investigative Site
Fort Washington, Maryland 20744
United StatesActive - Recruiting
Capitol Cardiology Associates
Lanham, Maryland 20706
United StatesSite Not Available
MD Medical Research
Oxon Hill, Maryland 20745
United StatesSite Not Available
Novartis Investigative Site
Oxon Hill, Maryland 20745
United StatesActive - Recruiting
Henry Ford Health Research
Detroit, Michigan 48202
United StatesSite Not Available
Ascension Providence Rochester
Rochester, Michigan 48307
United StatesSite Not Available
Novartis Investigative Site
Rochester, Michigan 48307
United StatesActive - Recruiting
Novartis Investigative Site
Belzoni, Mississippi 39038
United StatesSite Not Available
Novartis Investigative Site
Southaven, Mississippi 38671
United StatesSite Not Available
Cardiology Assoc Research LLC
Tupelo, Mississippi 38801
United StatesSite Not Available
Novartis Investigative Site
Tupelo, Mississippi 38801
United StatesActive - Recruiting
NexGen Research
Lima, Ohio 45801
United StatesSite Not Available
Novartis Investigative Site
Lima, Ohio 45805
United StatesActive - Recruiting
Novartis Investigative Site
Greenville, South Carolina 29607
United StatesActive - Recruiting
The Research Center of the Upstate
Greenville, South Carolina 29607
United StatesSite Not Available
Main Street Physicians Care
Little River, South Carolina 29566
United StatesSite Not Available
Novartis Investigative Site
Little River, South Carolina 29566
United StatesActive - Recruiting
University of Tennessee Health Science Center .
Memphis, Tennessee 38105
United StatesSite Not Available
Novartis Investigative Site
Tullahoma, Tennessee 37388
United StatesActive - Recruiting
Tennessee Center For Clinical Trials
Tullahoma, Tennessee 37388
United StatesSite Not Available
Tennessee Center For Clinical Trials .
Tullahoma, Tennessee 37388
United StatesSite Not Available
DFW Clinical Research LLC
Dallas, Texas 75234
United StatesSite Not Available
Novartis Investigative Site
Dallas, Texas 75234
United StatesActive - Recruiting
Carient Heart and Vascular
Manassas, Virginia 20109
United StatesSite Not Available
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesSite Not Available
Manassas Clinical Research Center .
Manassas, Virginia 20110
United StatesSite Not Available
Novartis Investigative Site
Manassas, Virginia 20109
United StatesSite Not Available
Novartis Investigative Site
Norfolk, Virginia 23504
United StatesActive - Recruiting
York Clinical Research
Norfolk, Virginia 23504
United StatesSite Not Available
Dominion Medical Associates
Richmond, Virginia 23219
United StatesSite Not Available
Dominion Medical Associates .
Richmond, Virginia 23219
United StatesSite Not Available
Novartis Investigative Site
Richmond, Virginia 23219
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.