EUCTR2009-013342-92-IT进行中（未招募）不适用
Effects of angiotensin-receptor blockade with olmesartan on carotid atherosclerosis in patients with hypertension: the CONFIRMatory olmesartan plaque regression study (CONFIRM) - ND
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
- 408
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
- •1.Male and female Caucasian outpatients aged > 40 years.
- •2.High BP defined as mean SeSBP/SeDBP ≥ 140/90 mmHg.
- •3.One or more of the following additional risk factors:
- •Dyslipidaemia (high-density lipoprotein (HDL)-cholesterol < 0.9 mmol/L or low-density lipoprotein (LDL)-cholesterol > 2.6 mmol/L, or triglycerides > 1.7 mmol/L);
- •Left ventricular hypertrophy;
- •Cardiocerebrovascular events > 6 months ago;
- •Presence of target organ damage.
- •4.Non-calcified (not marked shadowing) plaque in the CC artery, in the internal carotid artery or the carotid bulb with a PV ≥ 0.040 cm? (≥ 40 ?L) according to the measurements of EUTARC.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Secondary or high grade hypertension including grade III hypertension (SeSBP of > 180 mmHg or SeDBP of > 105 mmHg).
- •2.Stroke, myocardial infarction within the previous 6 months.
- •3.Interventional or surgical vascular treatment within the previous 3 months.
- •4.Presence of significant narrowing of the aortic or bicuspid valve and severe obstruction of cardiac outflow (hypertrophic cardiomyopathy).
- •5.Symptomatic heart failure.
- •6.Diabetes.
- •7.Chronic obstructive pulmonary disease (COPD) or asthma.
- •8.Claudicatio intermittens stage II b or higher.
- •9.Clinical evidence of severe renal disease [including renovascular occlusive disease, nephrectomy and/or renal transplant, creatinine clearance of < 30 mL/min), macroalbuminuria (> 300 mg albumin/24 hours or 300 ?g albumin/mg creatinine)].
- •10.Treatment with angiotensin converting enzyme (ACE)-inhibitors or angiotensin-receptor blockers (ARBs) during last 3 months.
- •11.Start of treatment with a lipid-lowering agent or modification of dosage within last 3 months.
- •12.Electrocardiographic (ECG) evidence of 2nd or 3rd degree atrioventricular (AV) block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia (< 50 beats/min at rest).
- •13.Known intolerance to study drugs.
- •14.Impaired liver function tests suggesting severe liver disorder.
- •15.Any life threatening disease.
- •16.Duplexsonographically determined stenosis of the common or internal carotid artery > 75%.
- •17.Plaque with marked shadowing from calcification.
- •18.Target plaques in CC artery extending into both internal and external arteries.
- •19.Pregnant or lactating female subjects.
- •20.Female subjects of childbearing potential without adequate contraception: intra-uterine devices, hormonal contraceptives, either oral, depot, patch or injectable and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. If a female becomes pregnant during the trial, she has to be withdrawn immediately (see section 9.4).
- •21.Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents.
- •22.Subject has previously entered this study.
- •23.Subjects who have received ATE within 30 days prior to entering the active treatment phase.
- •24.Subjects who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period.
- •25.Subjects with history of alcohol and or drug abuse.
- •26.Subjects with known malabsorption syndrome.
- •27.Subjects who had donated or lost 450 mL or more blood during the last three months before screening.
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