EUCTR2007-003131-23-DE进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 264
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
- 性别
- All
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, as:
- •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:
- •Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
- •Triglyceride level = 150 mg/dL
- •High Density Lipoprotein (HDL) < 40 mg/dL for men and < 50 mg/dL for women
- •Fasting blood glucose = 110 mg/dL and < 126 mg/dL (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
- •High Density Lipoprotein (HDL) < 40 mg/dL for men and < 50 mg/dL for women
- •Fasting blood glucose = 110 mg/dL and < 126 mg/dL (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 and < 126 mg/dL (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 Informed Consent Form (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 one of the following criteria at Screening visit (Visit 1) or at Baseline (Visit 2) will be disqualified from entering the study:
- •1. Females who are pregnant or plan a pregnancy during the time of the trial, are nursing, or are of childbearing potential and not using adequate and highly effective methods of contraception prior to and during the study.
- •Note: a female of non-childbearing potential will be defined as one who has been postmenopausal for at least one year or has been surgically sterilized or had a hysterectomy at least three months prior to the start of the study (Visit 1); adequate and highly effective method of contraception is defined as those resulting in a low failure rate (i.e. less than 1% per year) when used correctly and consistently, such as implants, injectables, combined oral contraceptives, hormonal intra-uterine devices, sexual abstinence, or vasectomised partner. The investigator will inform the applicable female patients about the respective method(s) in detail prior to study start. If a female becomes pregnant during the study, she has to be withdrawn immediately.
- •2. Type 1 and type 2 diabetes
- •3. High range” mild hypertension (ie Systolic Blood Pressure [SBP]: 150 - < 160 mmHg and/or Diastolic Blood Pressure [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, 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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