The Chymase Angiotensin-(1-12) Axis in Hypertensive Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Presence of human sequence of Ang-(1-12) in plasma ten untreated essential hypertensive subjects at baseline
研究概览
简要总结
Determine the presence of the human sequence of Angiotensin-(1-12) in plasma of ten untreated hypertensive subjects and after 4 week with Lisinopril 40 mg every day. Determine the blood pressure reduction with Lisinopril 40mg.
详细描述
Determine the presence of the human sequence of Ang-(1-12) in the plasma of ten normal male and female hypertensive patients at baseline and after 4 weeks on Lisinopril 40mg every day. Measure concentrations of Ang-(1-12) in either spot urine collections from ten male and female hypertensive patients at baseline and after 4 weeks of Lisinopril 40mg every day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of reading, comprehending the consent process and providing written informed consent to participate in the study
- •Subject willing to comply with all study visits/procedures and be available for the duration of the study
- •Male or female 40 years of age to 75 years of age
- •Male and female subjects naive to anti-hypertensive medications or receiving no anti-hypertensive medication for at least 6 months prior to visit 1
- •Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood pressure of equal/over 90 mm Hg and equal/less 109 mm Hg and/or Systolic blood pressure equal/over 140 mm Hg and equal/less 179 mm Hg on visit 1
- •Women may be enrolled if all three of the following criteria are met:
- •Have a negative urine pregnancy test at visit 1, for females of childbearing potential Are not breastfeeding Do not plan to become pregnant during the study And if one of the following three criteria is met Have had a hysterectomy or tubal ligation at least six months prior to signing the informed consent form Have been postmenopausal for at least one year Are of childbearing potential and will practice one of the following methods of birth control though out the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide. Abstinence, partner's vasectomy are not acceptable methods of contraception
排除标准
- 未提供
研究组 & 干预措施
Determine the presence of the human sequence of Ang-(1-12) in plasma on no medications
Determine the presence of the human sequence of Ang-(1-2) in the plasma of ten normal male and female hypertensive patients at baseline on no medications.
干预措施: Determine the presence of Human sequence Ang-(1-12) on no medication (Other)
Determine the presence of human sequence of Ang-(1-12) on Lisinopril 40 mg every day
Determine the presence of the human sequence of Ang-(1-12) in the plasma of 10 normal male and female hypertensive patients at baseline and after four weeks on Lisinopril 40 mg every day
干预措施: Human sequence Ang-(1-12) on Lisinopril 40mg every day (Drug)
结局指标
主要结局
Presence of human sequence of Ang-(1-12) in plasma ten untreated essential hypertensive subjects at baseline
时间窗: At baseline
Determine the presence of the human sequence of Ang-(1-12) in plasma of ten untreated hypertensive subjects at baseline
次要结局
- Presence of human sequence of Ang-(1-12) in plasma of ten subjects on four weeks of treatment on Lisinopril 40 mg every day(Four weeks)
研究者
Henry Anthony Punzi
Medical Director
Trinity Hypertension & Metabolic Research Institute