Starting soon
Phase 2
A Phase II Study of VB19055 in Uncontrolled or Resistant Hypertension
Condition(s) studied
HypertensionResistant HypertensionUncontrolled Hypertension
Investigational drug(s) / intervention(s)
VB19055 Dose A QDVB19055 Dose B QDVB19055 Dose C QDVB19055 placebo QD
VB19055 Dose A QD: VB19055 Dose A orally once daily (QD) for 12 weeks
VB19055 Dose B QD: VB19055 DoseB orally once daily (QD) for 12 weeks
VB19055 Dose C QD: VB19055 Dose C orally once daily (QD) for 12 weeks
VB19055 placebo QD: VB19055 placebo orally once daily (QD) for 12 weeks
Study summary
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
Inclusion Criteria:
* 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.)
* Meet at least one of the following two criteria:
1. 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;
2. 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.
* Serum potassium (K⁺) ≥3.5 and \<5.0 mmol/L at screening (local laboratory);
* Morning (08:00 ± 2 hours) serum cortisol \>3 µg/dL (local or central laboratory);
* Female participants of childbearing potential agree to no pregnancy plans and use highly effective contraception from ICF signing until 30 days after last dose; male participants agree to no fertility plans and use highly effective contraception from ICF signing until 90 days after last dose (see Appendix 2 for details);
* Voluntarily participate in this clinical study and have the capacity to sign the informed consent form.
Exclusion Criteria:
* 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;
* New York Heart Association (NYHA) Class III or IV chronic heart failure at screening;
* Glycated hemoglobin (HbA1c) \>9.5% at screening;
* Adrenal insufficiency diagnosed within 6 months prior to ICF signing;
* Any of the following abnormal laboratory/physical examination findings at screening:
1. Serum sodium \<135 mmol/L;
2. Mean seated SBP ≥170 mmHg or mean seated DBP ≥110 mmHg;
3. Aspartate aminotransferase (AST) \>3.0 × upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3.0 × ULN;
4. Total bilirubin \>2.0 × ULN, unless the participant has a history of Gilbert's syndrome;
5. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m²;
6. Body mass index (BMI) \<18 kg/m² or ≥45 kg/m²;
7. Any of the following ECG abnormalities: heart rate \<45 bpm or \>110 bpm; QT interval corrected by Fridericia's formula (QTcF) \>470 ms;
8. Clinically significant abnormal chest imaging (chest X-ray or computed tomography \[CT\]) assessed by the investigator as posing a safety risk;
9. Positive hepatitis B surface antigen (HBsAg) with possible viral replication (positive HBV DNA) as judged by the investigator based on further testing, or positive anti-hepatitis C virus (HCV) antibody, or positive human immunodeficiency virus (HIV) antibody.
Primary outcome measure(s)
- Change from baseline in seated clinic systolic blood pressure at Week 12. — at the end of the 12-week treatment period
Trial sites (24)
| Facility | City | Region | Status |
| The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology |
Baotou |
China |
|
| Peking University People's Hospital |
Beijing |
China |
|
| The Third Hospital of Changsha |
Changsha |
China |
|
| The Third Xiangya Hospital of Central South University |
Changsha |
China |
|
| Chengdu Second People's Hospital |
Chengdu |
China |
|
| The Second Affiliated Hospital of Chongqing Medical University |
Chongqing |
China |
|
| Daqing People's Hospital |
Daqing |
China |
|
| The First Hospital of Hebei Medical University |
Hebei |
China |
|
| The First Affiliated Hospital of University of South China |
Hengyang |
China |
|
| Affiliated Hospital of Jining Medical University |
Jining |
China |
|
| The Third People's Hospital of Luoyang |
Luoyang |
China |
|
| Zhongda Hospital, Southeast University |
Nanjing |
China |
|
| Panjin Liaohe Oilfield Gem Flower Hospital |
Panjin |
China |
|
| Qilu Hospital of Shandong University |
Shandong |
China |
|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine |
Shanghai |
China |
|
| Shanxi Cardiovascular Hospital |
Shaxi |
China |
|
| Liaoning Provincial People's Hospital |
Shenyang |
China |
|
| Shengjing Hospital of China Medical University |
Shenyang |
China |
|
| Suzhou Municipal Hospital of Anhui Province |
Suzhou |
China |
|
| China Resources WISCO General Hospital |
Wuhan |
China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
Wuhan |
China |
|
| The First People's Hospital of Xinxiang |
Xinxiang |
China |
|
| The Seventh People's Hospital of Zhengzhou City |
Zhengzhou |
China |
|
| Zhengzhou Central Hospital |
Zhengzhou |
China |
|
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