Actively Recruiting
To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension
Led by Suzhou Alphamab Co., Ltd. · Updated on 2025-09-25
60
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to compare the change from baseline in systolic blood pressure between KN060 and placebo in patients with essential hypertension over 12 weeks; the secondary objectives are to assess the safety and tolerability of KN060 and to assess the pharmacokinetic and pharmacodynamic properties and immunogenicity of KN060 in patients with essential hypertension. The main questions it aims to answer are: * To verify the efficacy of KN060 in patients with essential hypertension * Safety of KN060 in Subjects Treated for Essential Hypertension Researchers will compare KN060 to placebo (0.9% sodium chloride 100ml) to assess the antihypertensive effect of KN060. Subjects will : * Receive KN060 or placebo by intravenous drip every two weeks for 6 doses. * AOBP, 24hABPM, HBPM,and safety were monitored and recorded.
CONDITIONS
Official Title
To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 65 years
- Patients with essential hypertension not receiving drug therapy or on stable monotherapy with no changes in medication or dose within 30 days before screening
- Mean sitting systolic blood pressure (AOBP) of 140 to less than 180 mmHg measured after at least 5 minutes rest, averaged from 3 measurements at least 1 minute apart
- Mean systolic blood pressure of 130 to 160 mmHg measured by 24-hour ambulatory blood pressure monitoring (24hABPM)
You will not qualify if you...
- Secondary hypertension due to kidney disease, endocrine disease, cardiovascular disease, or moderate to severe obstructive sleep apnea without CPAP treatment
- Grade 3 (severe) hypertension: mean sitting systolic blood pressure (AOBP) 180 mmHg or higher and/or diastolic blood pressure 110 mmHg or higher; mean 24hABPM systolic blood pressure above 160 mmHg and/or diastolic blood pressure 100 mmHg or higher
- History of hypertensive emergencies or severe hypertension symptoms including headache, chest tightness, irritability, and nosebleeds
- High risk of bleeding or abnormal bleeding-related indicators
- Long-term use of anticoagulants or antiplatelet drugs including aspirin
- Use of any drugs affecting blood pressure within 30 days before dosing or planned use during the study
- Type 2 diabetes with poor blood glucose control defined by fasting blood glucose over 7.8 mmol/L, 2-hour postprandial/random blood glucose over 10.0 mmol/L, or HbA1c over 7%
- Any cardiovascular event within 6 months prior to screening
- Unstable heart disease such as uncontrolled arrhythmia, atrial fibrillation, heart failure NYHA class III or higher, severe left ventricular hypertrophy, or history of valvular heart disease
- Significant abnormal heart rate, arrhythmia, or myocardial ischemia on 12-lead ECG
- Echocardiography showing heart failure with left ventricular ejection fraction (LVEF) less than 50% or abnormal ventricular diastolic function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yanrong Dong, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here