ACTRN12617001192370已完成1 期
A phase I/IIa study to assess safety, tolerability, pharmacokinetic, pharmacodynamic effects and exploratory efficacy of two doses of AGMG0201 in patients with essential hypertension.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 79 Years（—）
- 性别
- All
入选标准
- •1. Provided voluntarily written informed consent. Willing and able to comply with protocol, and attend all study visits
- •2. Males or females of non-childbearing potential, aged more than or equal to 18 years and less than 80 years.
- •3. Body Mass Index (BMI) less than or equal to 35 kg/m2
- •4. Adequate venous access
- •5. Mild to moderate hypertension, defined as mean systolic blood pressure (SBP) 140-179 mmHg AND/OR mean diastolic blood pressure (DBP) of 90-109 mmHg (inclusive), who are either not currently using antihypertensive medications or on a single or on a regimen of a combination of ACEi + CCB, ACEi + diuretic, ARB + CCB or ARB + diuretic, and are willing to discontinue current antihypertensive medications for at least 14 days prior to first vaccination and 90 days after the booster vaccination. No clinically significant abnormalities that would contraindicate participation
- •6. Willing and able to comply with requirements of study protocol, and attend all study visits.
排除标准
- •Participants with any of the following criteria will not be eligible for participation in this study:
- •1. Participants who have been using two or more antihypertensive medications, excluding the combination of ACEi plus CCB, ACEi plus diuretic, ARB plus CCB or ARB plus diuretic, prior to the first screening visit (Screen1)
- •2. Participants unable to safely discontinue antihypertensive medications for a minimum of 4.5 months, as required by protocol
- •3. Severe hypertension at screening, defined as mean SBP greater than or equal to 180 mmHg OR mean DBP greater than or equal to 110 mmHg
- •4. Orthostatic hypotension, defined as a decrease in mean SBP of greater than or equal to 15 mmHg within three minutes of standing when compared with blood pressure from the semi-supine position at screening (assessed at the second screening visit (Screen2) if volunteer on antihypertensive medication at the first screening visit (Screen1))
- •5. Any history of intolerance to dihydropyridine CCBs
- •6. Any history of intolerance to ACE inhibitors or Angiotensin II antagonists
- •7. Participants of African descent, defined as having both parents identifying themselves as being of African origin
- •8. Renal insufficiency, defined as Creatinine Clearance less than or equal to 40 ml per min, as determined by the Cockcroft Gault equation at screening (assessed at the second screening visit (Screen2) if volunteer on antihypertensive medication at the first screening visit (Screen1))
- •9. Serum potassium greater than upper limit of normal (ULN) at Screening (assessed at the Screen2 visit if volunteer on antihypertensive medication at Screen1; if the volunteer was taking ARBs at the Screen1 and potassium level is still elevated at Screen2, the participant may be re-screened 2 weeks later)
- •10. Proteinuria or hematuria with urine dipstick greater than or equal to 2+ protein or greater than or equal to 1+ blood at screening or at any time within the 6 months prior to screening (assessed at the second screening visit (Screen2) if volunteer on antihypertensive medication at the first screening visit (Screen1))
- •11. Participants with secondary hypertension
- •12. Participants with mental health conditions requiring current pharmacological treatment
- •13. History of macrovascular complications resulting from type II diabetes mellitus or poorly controlled diabetes as evidenced by a haemoglobin A1c (HbA1c) greater than or equal to 8.5 % at screening.
- •14. AST greater than 3 times ULN and/or ALT greater than 3 times ULN at screening
- •15. History or presence of allergic symptoms such as bronchial asthma (within past three months), or drug-induced immediate hypersensitivity
- •16. History or presence of malignancy, HIV, hepatitis (B or C), syphilis, immunosuppressive disease or clinically significant autoimmune disease which may affect the participant’s normal immune response. Treated basal cell or squamous cell carcinoma of the skin, or low grade cancers that are stable and not interfering with exercise may be allowed with permission from the Medical Monitor
- •17. Presence of any clinically significant central nervous system disease associated with persistent neurological abnormalities.
- •18. Presence or history of any ischaemic heart disease, arrhythmias, or cerebrovascular disease
- •19. Family history (1st degree family member) of sudden death of collapse indicative of long QT syndrome
- •20. QTcF greater than or equal to 450 milliseconds at screening
- •21. Participants on medications that co
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