An efficacy, safety, tolerability and dose finding study of XXB750 in resistant hypertension patients
- Conditions
- Resistant hypertensionMedDRA version: 21.1Level: LLTClassification code 10081349Term: Resistant hypertensionSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-005738-41-IT
- Lead Sponsor
- OVARTIS PHARMA AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 170
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 = 145 mmHg despite treatment with stable (i.e., unchanged for =4 weeks), maximally tolerated doses of three antihypertensive drugs of different classes, specifically an ACEI/ARB, a long-acting dihydropyridine CCB, and a thiazide or thiazide-like diuretic.
Refer to Section 10.8 for minimum required doses of some commonly prescribed drugs in those classes.
4. Mean 24hr SBP =135 mmHg (measured by ABPM) at the end-of Runin-Visit (Visit 30) on treatment with maximally tolerated doses of an ACEI/ARB, a long-acting dihydropyridine CCB, and a thiazide or thiazidelike diuretic.
Additional inclusion criteria are described in the clinical study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Office msSBP <140 mmHg (at Visit 20 or Visit 30) OR 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 =105 mmHg measured by ABPM at the end of the run 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 received an MRA 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 =42 cm.
12. Hospitalization for hypertensive emergency / crisis within the 12 months prior to screening.
13. Received any antihypertensive medication other than the CCB, ACEI/ARB, and thiazide/thiazide-like diuretic components of the triple background antihypertensive therapy, including sacubitril/valsartan within the 4 weeks before screening (Visit 1). Participants receiving beta blockers and prostate-specific alpha blockers (e.g., tamsulosin) are allowed in the study only if those medications are being used for nonhypertension indications and benign prostatic hypertrophy, respectively.
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 Visit1.
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 or other prohibited medications during of the study (i.e., required use for longer than 1 week).
23. Pregnant, nursing or planning to bec
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method