Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- SBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response
研究概览
简要总结
This is a pharmacogenomic prospective , four-arms, parallel groups, active comparator controlled study in essential hypertensive patients never treated before.
Each patient will be genotyped for SNPs (single nucleotide polymorphism) in preliminary genetic profiles and will be treated according to their genetic profile with Peri (Perindopril) 4 mg or HCTZ ( hydrochlorothiazide) 12.5 mg.
详细描述
At screening visit each patient will be genotyped for SNPs in preliminary genetic profiles with a custom SNP array.
The therapy scheme includes 2-4-week run-in period after which eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg. Titration to Peri 8 mg or HCTZ 25 mg could be possible after one month treatment.
Patients without any genetic profile will be randomly assigned to HCTZ or Peri treatment as control groups.
The treatment period will last 8 weeks, while the study about 10-12 weeks
Four cases may occur:
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female patients aged 25-60 years.
- •Naive hypertensive patients (newly diagnosed, never treated before).
- •Documented mild to moderate arterial hypertension, as defined below:
- •At Visits 1 and 2 (week -4 and week -2 run-in period) the mean of the last 3 consecutive readings of office SBP must be >= 140 mmHg and/or DBP must be >=90 mmHg, when measured by office blood pressure (OBP);
- •At Visit 3 (week 0) enrolment , the mean of the last 3 consecutive readings of SBP must be >= 140 mmHg and <160 mmHg, and DBP must be >= 90 mmHg and <110 mmHg, when measured by OBP.
- •Signed informed consent for genotyping.
排除标准
- •known causes of secondary hypertension;
- •pregnant, nursing women or women of childbearing potential taking anti-contraceptive medication;
- •severe or malignant hypertension;
- •history of renal artery disease;
- •significant renal disease (estimated creatinine clearance less than 60 mL/min);
- •hepatic disease;
- •cardiac diseases (myocardial infarction, atrial fibrillation, etc);
- •diabetes (fasting plasma glucose >125mg/dL);
- •statin treatment;
- •obesity (BMI>30 kg/m2).
研究组 & 干预措施
Peri profile yes
patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
干预措施: Peri (Drug)
HCTZ profile yes
patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
干预措施: HCTZ (Drug)
Peri no profile
patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
干预措施: Peri (Drug)
HCTZ no profile
patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
干预措施: HCTZ (Drug)
结局指标
主要结局
SBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response
时间窗: 4 and 8 weeks
Difference in SBP and DBP variation after 4 and 8 weeks of therapy according to the presence or not of specific genetic profile for each drugs
次要结局
- Profiles implementation(in the three months after the end of the study)
研究者
Chiara Lanzani
medical doctor
Ospedale San Raffaele