A Phase II Study of VB19055 in Uncontrolled or Resistant Hypertension

ConditionsHypertension Resistant Hypertension Uncontrolled Hypertension

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorZhejiang Yangli Pharmaceutical Technology Co., Ltd.

About this trial

A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial of VB19055 for 12 weeks in 240 adults with uncontrolled hypertension (including resistant hypertension).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male and female aged ≥18 years;

Mean seated systolic blood pressure (SBP) ≥140 mmHg and <170 mmHg at screening, and SBP ≥135 mmHg and <170 mmHg at randomization (Mean seated SBP/DBP is defined as the average of 3 seated SBP/DBP measurements obtained by automated office blood pressure measurement at a single clinic visit. If the trial participant has not taken routine antihypertensive medication prior to the visit, a repeat mean blood pressure measurement may be performed within 2 days after dosing.)

Uncontrolled hypertension: At screening and randomization, as judged by the investigator, stably taking antihypertensive medications of two different therapeutic classes at maximum tolerated dose for ≥4 weeks (at least one must be a non-potassium-sparing diuretic). Beta-blockers used for other indications (e.g., migraine, heart failure, coronary artery disease) shall not count toward antihypertensive medications for eligibility;

Resistant hypertension: At screening and randomization, as judged by the investigator, stably taking antihypertensive medications of ≥3 different therapeutic classes at maximum tolerated dose for ≥4 weeks (at least one must be a non-potassium-sparing diuretic). Beta-blockers used for other indications (e.g., migraine, heart failure, coronary artery disease) shall not count toward antihypertensive medications for eligibility.

Disqualifiers

Known causes of secondary hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism/hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation, or obstructive sleep apnea syndrome being treated with continuous positive airway pressure (CPAP) (participants with primary aldosteronism may be considered for enrollment unless adrenalectomy is planned before study completion);

Have undergone coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or any major surgery (e.g., valve replacement, peripheral artery bypass surgery) within 6 months prior to ICF signing, or plan to undergo such procedures during the study;

Arrhythmia requiring treatment or left bundle branch block at screening;

Known chronic permanent atrial fibrillation;

Trial design

Design model

Parallel

Treatments tested in this trial

VB19055 Dose A QD
Drug
VB19055 Dose A orally once daily (QD) for 12 weeks
VB19055 Dose B QD
Drug
VB19055 DoseB orally once daily (QD) for 12 weeks
VB19055 Dose C QD
Drug
VB19055 Dose C orally once daily (QD) for 12 weeks
VB19055 placebo QD
Drug
VB19055 placebo orally once daily (QD) for 12 weeks

Treatment groups

240 Participants

are divided into 4 treatment groups

Group A: VB19055 Arm AExperimental treatment 1 intervention

Group B: VB19055 Arm BExperimental treatment 1 intervention

Group C: VB19055 Arm CExperimental treatment 1 intervention

Group D: VB19055 placebo QDPlacebo comparator 1 intervention