EUCTR2007-003131-23-GB进行中（未招募）1 期
Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic Syndrome
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects must satisfy all of the following criteria at Screening visit (Visit 1) and at Baseline (Visit 2) to be included in the study; except inclusion criterion 3, which needs only be satisfied at the screening visit:
- •1. Male and female outpatients
- •2. Age = 18 and = 75 years
- •3. Hypertension and metabolic syndrome defined, according to the ATP III/ IDF 2005 and ESH/ESC 2007 definitions with modifications:
- •a) BP = 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or low range” mild hypertension) and at least 1 of the following traits at:
- •Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
- •Triglyceride level = 150 mg/dL (= 1.7 mmol/L)
- •High Density Lipoprotein (HDL) < 40 mg/dL (< 1.0 mmol/L) for men and < 50 mg/dL (< 1.3 mmol/L) for women
- •Fasting blood glucose = 110 mg/dL (= 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes)
- •b)BP = 120/80 mmHg and < 130/85 mmHg (ie normal BP) and one antihypertensive treatment at Screening, and normal to low range” mild hypertension (ie = 130/85 and < 150/95 mmHg) at Baseline, and at least 1 of the following traits:
- •Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
- •Triglyceride level = 150 mg/dL (= 1.7 mmol/L)
- •High Density Lipoprotein (HDL) < 40 mg/dL (< 1.0 mmol/L) for men and < 50 mg/dL (< 1.3 mmol/L) for women
- •Fasting blood glucose = 110 mg/dL (= 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes)
- •c)BP = 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or low range” mild hypertension) and current treatment with a lipid-lowering agent and at least 1 of the following traits:
- •Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
- •Fasting blood glucose = 110 mg/dL (= 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes)
- •4.No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months (including ACE, ARB and renin-inhibitors).
- •5.Signature of the ICF
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who meet any of the following criteria at Screening visit (Visit 1) or at Baseline (Visit 2) will be disqualified from entering the study:
- •1. Pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception)
- •2. Type 1 and type 2 diabetes
- •3. High range” mild hypertension (ie SBP: 150 - < 160 mmHg and/or DBP: 95 - < 100 mmHg)
- •4. Moderate, severe or resistant hypertension (see definitions below )
- •SBP (mmHg)DBP (mmHg)
- •Moderate hypertension160 – 179and/or100 – 109
- •Severe hypertension= 180and/or= 110
- •Resistant hypertensionHypertension resistant to treatment
- •5. Secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushing’s syndrome
- •6. Serious disorders which may limit the ability to evaluate the efficacy or safety of the study drug, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic (criteria for metabolic syndrome; see Section 4.1.1), haematological, oncological, neurological, or psychiatric diseases
- •7. History of the following pathologies within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, stroke, or transient ischemic attack
- •8. Clinically relevant abnormal laboratory values
- •9. Contraindication to OM
- •10. Previously screened subjects, unless they failed inclusion criterion 3 at screening and/or baseline under earlier protocol requirements.
- •11. Alcohol or drug of abuse in the past 2 years
- •12. Planned hospitalization during the study period
- •13. Participation in any other clinical study within 30 days prior to Screening visit
- •14. Enrolment of the Investigator(s), site staff, or their family members
研究者
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