NCT01132768终止4 期
Effects of Angiotensin-Receptor Blockade With Olmesartan on Carotid Atherosclerosis in Patients With Hypertension: The Confirmatory Olmesartan Plaque Regression Study
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company0 个研究点目标入组 114 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 114
- 主要终点
- Change in carotid plaque volume
研究概览
简要总结
Effect of olmesartan medoxomil (20-40 mg) on plaque regression in hypertensive patients with carotid atherosclerosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Caucasian outpatients aged > 40 years.
- •High BP defined as mean SeSBP/SeDBP ≥ 140/90 mmHg.
- •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;
- •Cardio-cerebrovascular events > 6 months ago;
- •Presence of target organ damage.
- •Non-calcified (not marked shadowing) plaque in the CC artery, in the internal carotid artery or the carotid bulb with a PV ≥ 0.040 cm³ (≥ 40 µL) according to the measurements of EUTARC.
排除标准
- •Secondary or high grade hypertension including grade III hypertension (SeSBP of > 180 mmHg or SeDBP of > 105 mmHg).
- •Stroke, myocardial infarction within the previous 6 months.
- •Interventional or surgical vascular treatment within the previous 3 months.
- •Presence of significant narrowing of the aortic or bicuspid valve and severe obstruction of cardiac outflow (hypertrophic cardiomyopathy).
- •Symptomatic heart failure.
- •Diabetes.
- •Chronic obstructive pulmonary disease (COPD) or asthma.
- •Claudication intermittens stage II b or higher.
- •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 µg albumin/mg creatinine)].
- •Treatment with angiotensin converting enzyme (ACE)-inhibitors or angiotensin-receptor blockers (ARBs) during last 3 months.
- •Start of treatment with a lipid-lowering agent or modification of dosage within last 3 months.
- •Electrocardiographic (ECG) evidence of 2nd or 3rd degree atrioventricular (AV) block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia (< 50 beats/min at rest).
- •Known intolerance to study drugs.
- •Impaired liver function tests suggesting severe liver disorder.
- •Any life threatening disease.
- •Duplex sonographically determined stenosis of the common or internal carotid artery > 75%.
- •Plaque with marked shadowing from calcification.
- •Target plaques in CC artery extending into both internal and external arteries.
- •Pregnant or lactating female subjects.
- •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).
- •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.
- •Subject has previously entered this study.
- •Subjects who have received ATE within 30 days prior to entering the active treatment phase.
- •Subjects who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period.
- •Subjects with history of alcohol and or drug abuse.
- •Subjects with known malabsorption syndrome.
- •Subjects who had donated or lost 450 mL or more blood during the last three months before Screening.
研究组 & 干预措施
Atenolol
Active Comparator
Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily.
干预措施: Atenolol (Drug)
Olmesartan medoxomil
Experimental
Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily.
干预措施: olmesartan medoxomil (Drug)
结局指标
主要结局
Change in carotid plaque volume
时间窗: 78 weeks (week 78 - week 0)
change in carotid plaque volume (PV) from baseline (week 0) as assessed by 3-D ultrasonography after 78 weeks of double-blind treatment with Olmesartan (OM) 20-40 mg daily compared to Atenololo (ATE) 50-100 mg daily (week 78 - week 0).
次要结局
- Percentage changes of PV from baseline to Week 52 for olmesartan versus atenolol.(52 weeks (week 52-week 0))
- Change in PV from baseline to Week 52 after adjustments for changes in SeDBP from baseline.(52 weeks (week 52 - week 0))
- Change in PV from baseline to Week 78 after adjustments for changes in SeSBP from baseline.(78 weeks (Week 78- week 0))
- Change in plaque volume after 52 weeks, olmesartan versus atenolol(52 weeks (week 52 - week 0))
- Percentage changes of PV from baseline to Week 78 for olmesartan versus atenolol.(78 weeks (week 78 - week 0))
- Change in seated diastolic blood pressure (SeDBP) from baseline to Week 52 for olmesartan versus atenolol.(52 weeks (week 52 - week 0))
- Change in seated diastolic blood pressure (SeDBP) from baseline to Week 78 for olmesartan versus atenolol.(78 weeks (week 78 - week 0))
- Change in seated systolic blood pressure (SeSBP) from baseline to Week 52 for olmesartan versus atenolol.(52 weeks (week 52 - week 0))
- Change in seated systolic blood pressure (SeSBP) from baseline to Week 78 for olmesartan versus atenolol.(78 weeks (week 78 - week 0))
- Change in PV from baseline to Week 78 after adjustments for changes in SeDBP from baseline.(78 weeks (Week 78 - week 0))
- Change in PV from baseline to Week 52 after adjustments for changes in SeSBP from baseline.(52 weeks (week 52 - week 0))
研究者
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