NCT00546052已完成3 期
52 Week Study to Evaluate the Effects of LOSARTAN 50 mg, 100 mg, 100/12.5 mg HCTZ, 100/25 mg HCTZ on Metabolic Parameters, Blood Pressure and Safety in Hypertensive Patients With Metabolic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,738
- 主要终点
- Change in Hemoglobin A1c Between 52 Weeks and Baseline
研究概览
简要总结
To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An Adult Patient (At Least 18 Years Of Age) With A Clinical Identification Of The Metabolic Syndrome Using The IDF Definition:
- •abdominal (central) obesity as defined by the waist circumference in men of > 102 cm and women of > 88 cm or a BMI equal or greater than 30 kg/m2
- •and untreated hypertension with bp equal or greater than 140/90 mm Hg but bp < 180/110 mm Hg
- •or a patient receiving one or two antihypertensive agent(s) (diuretics, ace inhibitors, angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) and whose blood pressure is not controlled:
- •bp equal or greater than 140/90 mm Hg but equal or less than 160/100 mm Hg
- •or a patient whose hypertension is controlled (< 140/90 mm hg) with a single anti-hypertensive agent (diuretics, ace inhibitors, and angiotensin II receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) but who is unsatisfied or experiencing side effects warranting a discontinuation of the previous treatment and at one of the following:
- •Fasting plasma glucose equal or greater than 5.6 mmol/L and < 7.0 mmol/L
- •Triglycerides > 1.7 mmol/L or specific treatment for this lipid abnormality
- •HDL-c in men < 0.9 mmol/L and in women < 1.1 mmol/L or specific treatment for this lipid abnormality
排除标准
- •A Patient With A Diagnosis Of Type II Diabetes Defined As Fasting Blood Glucose Level Equal Or Greater Than 7.0 Mmol/L Or A 2hpg In A 75-G OGTT Equal Or Greater Than 11.1 Mol/L Or Using Any Anti-Hyperglycemic Agents
- •Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Or Hypertensive Encephalopathy)
- •Patient Intolerant To Any Component Of Losartan 50 Mg / Losartan 100 Mg / Losartan 100 Mg + Hctz 12.5 Mg / Losartan 100 Mg + Hctz 25 Mg Or With A Documented History Of Angioedema
- •Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance On The Basis Of The Case History Or A Recent Laboratory Test (Serum Creatinine > 130 Mmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 2 Times Above The Normal Range, Alt > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L)
- •Patient With Symptomatic Heart Failure (Classes 3 And 4)
- •Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
- •Patient Who Has Undergone Percutaneous Coronary Angioplasty Or Coronary Artery Bypass Within The Last 3 Months
- •Pregnant Woman Or A Woman Of Childbearing Potential
研究组 & 干预措施
1
Experimental
Losartan (MK0954) / Losartan + HCTZ (MK0954A)
干预措施: losartan potassium (+) hydrochlorothiazide (Drug)
结局指标
主要结局
Change in Hemoglobin A1c Between 52 Weeks and Baseline
时间窗: 52 Weeks - Baseline
Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments
时间窗: 52 Weeks - Baseline
Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.
次要结局
- Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments(52 Weeks - Baseline)
- Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments(52 Weeks - Baseline)
- Target Blood Pressure(52 Weeks)
研究者
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