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 hypertensio
- Conditions
- Resistant Hypertension10057166
- Registration Number
- NL-OMON53418
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
• Male and female participants who are >=18 years old.
• 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.
• 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.
• Subjects with the following blood pressures at the specified time points are
not eligible to participate in the study:
a. Office msSBP <140 mmHg at Visit 20 OR
b. Office msSBP >=180 mmHg or office msDBP >=110 mmHg at the end-of-run-in visit
(Visit 30) OR
c. 24h mean SBP >170 mmHg or 24h mean DBP >105mmHg measured by ABPM at the end
of the run-in (Visit 30).
• 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).
• Estimated GFR <30 mL/min/1.73m2 at screening (Visit 1) or at end-of-run-in
visit (Visit 30).
• Serum potassium >5.0 mmol/L (or equivalent plasma potassium value) at
screening or end-of-run-in visit (Visit 30).
• Current therapy with a mineralocorticoid receptor antagonist (MRA) or
sacaubitril/valsartan, received an MRA or sacaubitril/valsartan within the 4
weeks prior to screening.
• 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.
• Receiving more than 4 antihypertensive medications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline in mean 24hr SBP at Week 12 (dose-response relationship)</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Change from baseline in mean 24hr SBP at Week 12<br /><br>• Average of changes from baseline ion mean 24hr SBP at Week 9 and at Week 12<br /><br>• The proportions of participants achieving blood pressure control defined as<br /><br>mean 24hr SBP <130 mmHg and mean 24hr DBP <80 mmHg at Week 12<br /><br>• Adverse events, safety laboratory parameters, and vital signs through end of<br /><br>treatment/study (EOT/EOS)</p><br>