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Tests treatment safety and results for Hypertension
Official title To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension
ClinicalTrials.gov ID: NCT07191899
What this study is testing
What is KN060?
KN060 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- men or women ≥ 18 years of age and ≤ 65 years of age;
- patients with essential hypertension who are not receiving drug therapy or are receiving stable monotherapy (stable therapy: no change in...
- AOBP mean sitting SBP ≥ 140 and \< 180 mmHg (at least 5 minutes rest before measurement, 3 measurements averaged over at least 1 minute apart) and...
You likely can't join if
- secondary hypertension: kidney disease, endocrine disease, cardiovascular disease and moderate to severe obstructive sleep apnea without CPAP...
- Grade 3 hypertension (severe): mean AOBP sitting SBP ≥ 180 mmHg, and/or DBP ≥ 110 mmHg; mean ABPM SBP \> 160 mmHg, and/or mean DBP ≥ 100 mmHg;
- Patients with a history of hypertensive emergencies, or hypertensive sub-emergencies who have severe hypertension with headache, chest tightness...
- high risk of bleeding or abnormal relevant indicators;
- long-term use of anticoagulants or antiplatelet drugs, including aspirin at any dose, due to treatment;
- currently using, or within 30 days before dosing or expected to use any drug or other component known to affect blood pressure during the study;
See the full eligibility criteria
- men or women ≥ 18 years of age and ≤ 65 years of age;
- patients with essential hypertension who are not receiving drug therapy or are receiving stable monotherapy (stable therapy: no change in antihypertensive drugs and doses within 30 days before screening);
- AOBP mean sitting SBP ≥ 140 and \< 180 mmHg (at least 5 minutes rest before measurement, 3 measurements averaged over at least 1 minute apart) and mean SBP ≥ 130 and ≤ 160 mmHg at 24 hours ABPM;
- secondary hypertension: kidney disease, endocrine disease, cardiovascular disease and moderate to severe obstructive sleep apnea without CPAP treatment;
- Grade 3 hypertension (severe): mean AOBP sitting SBP ≥ 180 mmHg, and/or DBP ≥ 110 mmHg; mean ABPM SBP \> 160 mmHg, and/or mean DBP ≥ 100 mmHg;
- Patients with a history of hypertensive emergencies, or hypertensive sub-emergencies who have severe hypertension with headache, chest tightness, irritability, and epistaxis;
- high risk of bleeding or abnormal relevant indicators;
- long-term use of anticoagulants or antiplatelet drugs, including aspirin at any dose, due to treatment;
- currently using, or within 30 days before dosing or expected to use any drug or other component known to affect blood pressure during the study;
- Type 2 diabetes with substandard blood glucose control: fasting blood glucose \> 7.8 mmol/L, or 2-hour postprandial blood glucose/random blood glucose \> 10.0 mmol/L, or HbA1c \> 7%;
- any cardiovascular event within 6 months prior to screening
- unstable heart disease, such as uncontrolled symptomatic arrhythmia, atrial fibrillation, heart failure NYHA ≥ III, severe left ventricular hypertrophy, or a history of valvular heart disease;
- 12-lead ECG showed significant abnormal heart rate, arrhythmia or myocardial ischemia;
- echocardiography revealed heart failure:LVEF\< 50%; abnormal ventricular diastolic function
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.