EUCTR2007-003131-23-IT进行中（未招募）1 期
Effect of olmesartan medoxomil on arterial stiffness and thickness in subjects with metabolic syndrome - ND
SANKYO EUROPE0 个研究点目标入组 350 人开始时间: 2008年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- 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: 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, as BP ≥ 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or ?low range? mild hypertension) and at least 2 of the following traits at: 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) 4.No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months. Note: treatment with Angiotensin II Receptor Blockers (ARB) or Angiotensin-Converting Enzyme Inhibitors (ACE) is not allowed within the last 6 months 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.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 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 hypertension 160 ? 179 and/or 100 ? 109 Severe hypertension ≥ 180 snd/or ≥ 110 Resistant hypertension Hypertension resistant to treatment 5.Secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushing?s syndrome 6.Inconsistent use of lipid-lowering agents (eg statins, fibrates) within 2 years prior to study start. Note: No use of lipid-lowering agents within 2 years is allowed. 7.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 8.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 9.Clinically relevant abnormal laboratory values 10.Contraindication to OM 11.Previously enrolled subjects 12.Alcohol or drug of abuse in the past 2 years 13.Planned hospitalization during the study period 14.Participation in any other clinical study within 30 days prior to Screening visit 15.Enrolment of the Investigator(s), site staff, or their family members
研究者
相似试验
已完成
3 期
Effect of Olmesartan Medoxomil on arterial stiffness and thickness in subjects with metabolic syndrome.hypertensionNL-OMON35439Daiichi Sankyo Europe10
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Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic SyndromeMetabolic Syndrome, HypertensionMedDRA version: 9.1Level: LLTClassification code 10052066Term: Metabolic syndromeMedDRA version: 9.1Level: LLTClassification code 10020772Term: HypertensionEUCTR2007-003131-23-BEDAIICHI SANKYO EUROPE GmbH264
进行中（未招募）
不适用
Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic SyndromeMetabolic Syndrome, HypertensionMedDRA version: 9.1Level: LLTClassification code 10052066Term: Metabolic syndromeMedDRA version: 9.1Level: LLTClassification code 10020772Term: HypertensionEUCTR2007-003131-23-NLDAIICHI SANKYO EUROPE GmbH350
进行中（未招募）
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Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic SyndromeMetabolic Syndrome, HypertensionMedDRA version: 9.1 Level: LLT Classification code 10052066 Term: Metabolic syndromeMedDRA version: 9.1 Level: LLT Classification code 10020772 Term: HypertensionEUCTR2007-003131-23-GBDAIICHI SANKYO EUROPE GmbH350
进行中（未招募）
不适用
Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic SyndromeMetabolic Syndrome, HypertensionMedDRA version: 9.1Level: LLTClassification code 10052066Term: Metabolic syndromeMedDRA version: 9.1Level: LLTClassification code 10020772Term: HypertensionEUCTR2007-003131-23-DEDAIICHI SANKYO EUROPE GmbH264