NCT00274144已完成4 期
Pilot Study: Inflammation and Coronary Artery Disease. Role of AT1 Receptor Antagonism
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Alterations in the inflammatory parameters: hsCRP, IL-6, IL-10, sICAM-1, TNF-alpha, MCP-1, LFA, MAC-1, L- selectin, FcyRIII and PECAM-1
研究概览
简要总结
Effects of AT1 receptor antagonist telmisartan on the primary endpoint inflammatory parameters in patients with coronary artery disease (CAD). Secondary endpoints are alterations in clinical course and blood pressure
详细描述
Methodology:
Randomised, double-blind and placebo-controlled parallel group design
Planned/actual number of subjects:
Enrolled: 40/50 randomised: 40/42 completed: 40/42
Diagnosis and main criteria for inclusion:
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
- Double
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated essential hypertension with a mean seated DBP < 95 mm Hg and a mean seated SBP < 160 mm Hg at the randomisation visit (baseline)
- •Coronary artery disease confirmed by cardiac catheterization
- •> 18 years of age
- •Ability to stop current antihypertensive therapy with ACE inhibitors, angioten-sin II receptor antagonist or lipid lowering therapy with statins without risk to the patient in the run-in period of two to four weeks and during the study period.
- •Ability to provide written informed consent.
排除标准
- •Acute coronary syndromes.
- •Acute or chronic heart failure (left ventricular ejection fraction < 45 %).
- •Symptomatic valvular heart disease.
- •Inflammatory diseases (e.g., acute infection, rheumatic diseases, collagenosis).
- •Pre-menopausal women (last menstruation < 1 year prior to start of run-in period) who:
- •Are not surgically sterile.
- •Are nursing.
- •Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable or injectable contraceptives.
- •Known or suspected secondary hypertension.
- •Mean sitting SBP > 160 mm Hg or mean sitting DBP > 95 mm Hg during any visit.
- •Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- •SGPT(ALT) or SGOT(AST) > than 2 times the upper limit of normal range .
- •Serum creatinine > 2.3 mg/dL.
- •Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one kidney.
- •Clinically relevant hypokalaemia or hyperkalaemia.
- •Uncorrected volume depletion.
- •Uncorrected sodium depletion.
- •Primary aldosteronism.
- •Hereditary fructose intolerance.
- •Biliary obstructive disorders.
- •Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
- •History of drug or alcohol dependency within 6 months.
- •Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol (cf. 4.2.1).
- •Current participation in another trial, or participation in a trial within a period of one month.
- •Known hypersensitivity to any component of the formulation.
- •Has no contra-indication to a placebo run-in period (e.g., recent stroke or MI).
- •Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan.
结局指标
主要结局
Alterations in the inflammatory parameters: hsCRP, IL-6, IL-10, sICAM-1, TNF-alpha, MCP-1, LFA, MAC-1, L- selectin, FcyRIII and PECAM-1
次要结局
- Alterations of clinical parameters such as clinical outcome, and changes in blood pressure. Safety and tolerability in terms of incidence and severity of adverse events, changes in physical examination, heart rate, laboratory parameters, and 12-lead-ECG.
研究者
研究点 (2)
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