Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Time to potassium rescue
研究概览
简要总结
Cicletanine, which has been approved and launched for hypertension in France and Germany, has promise beyond hypertension in critically-unmet needs such as diabetes. It is evident from in vitro, animal and human studies that cicletanine's optimal dose in diabetes and other challenging, critically-unmet needs is likely to be higher than that for hypertension. Cicletanine's maximum tolerated dosage is not known, but the drug's dose-limiting effects are documented to be potassium loss and sodium loss from thiazide-type activity (one of the therapeutic mechanisms the drug is known to have); such thiazide-type losses are known to be reversed safely by magnesium. This trial explores the ability of magnesium to enhance cicletanine safety at higher doses in a trial involving patients with hypertension complicated by diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sitting SBP (systolic blood pressure) > 150 mmHg (millimeters of mercury) after five minutes' rest.
- •Type II diabetes, with HbA1c between 8.5 and 11.5%. If a patient at screening presents outside of this range, the investigator may elect to re-screen a patient once to determine further the patient's eligibility.
- •Age >18 and < 80 years of age
- •BMI between 20 and 35, inclusive
- •Have been stable on existing therapy for at least 30 days prior to initiation of cicletanine (Visit 2)
- •a. no change in antihypertensive nor antihyperglycemia agent dose within 30 days prior to screening visit.
- •Willing to comply with the requirements of the protocol.
- •Willing to provide written Informed Consent to participate in the study approved by an appropriately constituted IRB (Institutional Review Board).
- •All females who are not post-menopausal should be using at least two forms of contraception during the entire study.
排除标准
- •Use of potassium supplementation over the past 30 days
- •Use of potassium-wasting diuretics, e. g., thiazides over the past 30 days
- •AST (aspartate aminotransferase; also abbreviated SGOT) outside normal range of 5 and 40 mg/dL inclusive
- •ALT (alanine aminotransferase; also abbreviated SGPT) outside normal range of 7 and 56 mg/dL inclusive
- •Laboratory findings outside of normal range can be considered grounds for exclusion at the discretion of the Sponsor, Medical Monitor and / or Principal Investigator
- •History of or positive laboratory test for HIV, HBV (hepatitis B virus) or HCV (hepatitis C virus)
- •Clinically significant psychiatric, addictive or neurologic disease or any other condition that, in the Investigator's opinion, would compromise his/her ability to give informed consent, participate fully in this study, or prevent adherence to the requirements of the study protocol
- •Evidence of unstable cardiovascular disease including intermittent atrial fibrillation or unstable angina within the 4 weeks prior to screening
- •History of myocardial infarction, coronary artery bypass graft surgery, or percutaneous cardiac intervention within the last 3 months
- •Clinically significant valvular heart disease in the opinion of the Investigator
- •History of cerebrovascular accident or transient ischemic attack within the last 3 months
- •Presence or history of malignancy that required significant medical intervention within the preceding 3 months and/or is likely to result in death within the next 2 years
- •Chronic renal impairment or renal insufficiency defined by a serum creatinine ³ 2.5 mEq/dL and/or the requirement for dialysis
- •The subject is lactating, breastfeeding, or pregnant
- •The subject has received any investigational medication within 30 days prior to the start of this study or be scheduled to receive another investigational drug during the course of this study
研究组 & 干预措施
Cicletanine
Patients will take escalating doses of cicletanine
干预措施: Cicletanine (Drug)
Cicletanine + magnesium
Patients will take escalating doses of cicletanine; patients will in addition take magnesium
干预措施: Cicletanine + magnesium (Drug)
结局指标
主要结局
Time to potassium rescue
时间窗: 13 weeks (duration of study)
The primary endpoint is the preservation of potassium levels at or above 3.3 mEq/L (milliequivalents per liter). A time to event model using the Log Rank test will be used to compare the Mg Group and those in the Non-Mg Group.
次要结局
- Average levels of sodium in patients on cicletanine with and without magnesium(13 weeks (duration of study))
- Reduction in systolic blood pressure vs. baseline(13 weeks (duration of study))
- Reduction in HbA1c vs. baseline(13 weeks (duration of study))
- Average levels of magnesium in patients on cicletanine with and without magnesium(13 weeks (duration of study))
- Reduction in diastolic blood pressure vs. baseline(13 weeks (duration of study))
- CRP (C reactive protein) levels(13 weeks (duration of study))
- Average levels of potassium in patients on cicletanine with and without magnesium(13 weeks (duration of study))