NCT00242814已完成4 期
A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities in Non Controlled Hypertensive Male Patients With Metabolic Syndrome
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 41
- 主要终点
- Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
研究概览
简要总结
The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment.
An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma stimulation) in 30 subjects (15 per arm).
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient written informed consent is signed prior to any trial specific procedures participation
- •male patients > 18 years
- •Mean seated SBP > 130mmHg and/or DBP > 85mmHg treated with antihypertensive drug(s)
- •with at least 2 more criteria of metabolic syndrome (NCEPT III). Biological data available within 6 months prior to enrollment visit.
- •abdominal obesity > 102 cm at screening
- •TG > 1.5 g/l
- •HDL < 0.4 g/l
- •Glycemia > 6 mmol/l
排除标准
- •Patients with any of the following conditions will be excluded from trial:
- •confirmed type 1 or 2 diabetic patients treated or not
- •secondary hypertension
- •Mean seated SBP>180 mmHg and/or DBP >110 mmHg at screening
- •hepatic and/or renal dysfunction as defined by the following laboratory parameters at visit 1:
- •SGPT (ALT) or SGOT (AST) ¿ twice the upper limit of the normal range
- •serum creatinine ¿ 2.3 mg/dL (or 203 ¿mol/L)
- •bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
- •patients post-renal transplant or with only one functioning kidney
- •clinically relevant hypokalemia or hyperkalemia at visit 1
- •uncorrected volume or sodium depletion at visit 1
- •primary aldosteronism
- •hereditary or known fructose intolerance
- •biliary obstructive disorders
- •patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-II receptor antagonists
- •history of drug or alcohol dependency within the previous six months
- •concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form
- •symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
- •unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
- •stroke less than six months prior to informed consent
- •sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
- •hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
- •known allergic hypersensitivity to any component of the formulations under investigation
- •concomitant therapy with lithium, cholestyramine or colestipol resins continued after visit 1
结局指标
主要结局
Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
时间窗: At week 6
次要结局
- Comparison of serum level of TNF alpha, IL-6, leptine, hsCRP, TG, HDL and blood pressure control between two groups. Adipocyte differentiation in 30 patients (PPAR gamma stimulation) between two groups.(At week 6)
研究者
研究点 (41)
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