NCT00546754已完成3 期
BP-EASE-A 12-Week, Multicenter, Open-Label, Randomized, Controlled Trial To Compare The Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Titrated as Needed to Losartan 100 mg/HCTZ 25 mg or Valsartan 160 mg/HCTZ 25 mg, in Patients With Essential Hypertension Who Have Not Achieved Target Blood Pressure With
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
- 808
- 主要终点
- Change in Systolic Blood Pressure From Baseline to Week 12
研究概览
简要总结
To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An Adult Patient 18 to 75 Years Of Age
- •Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:
- •Either systolic or diastolic blood pressure > 140/90 mm Hg up to 180/110 mm Hg (inclusive)
- •Either systolic or diastolic blood pressure > 130/80 mm Hg up to 160/100 mm Hg (inclusive) for diabetic patients
- •Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:
- •Surgically sterilized female
- •Postmenopausal female > 45 years of age with > 2 years since her last menses
- •Non-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy [either 2 barrier methods or a barrier method plus a hormonal method]; or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication; or (3) only engage in heterosexual activity with surgically sterilized male partner(s) throughout the study starting with Visit 1 and for 14 days after the last dose of study medication
- •Patient judged to be in otherwise good, stable health on the basis of medical history and physical examination
排除标准
- •Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)
- •Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
- •Patient taking allopurinol
- •Patient Previously Shown To Be Intolerant To Any Component Of Losartan Valsartan, Or HCTZ Or With A Documented History Of Angioedema/Anaphylaxis
- •Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Umol/L Or Creatinine Clearance < 45 Ml/Min, Aspartate transaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
- •Patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months
- •Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that need a chronic inflammatory therapy such as prednisone or other steroid agents
- •Patient with symptomatic heart failure (classes 3 and 4)
- •Patient with a history of stroke within the last 6 months
- •Patient with coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction, all that occurred less than 6 months prior to visit 1 or has unstable angina
- •Patient having participated in an investigational drug program in the last 30 days (prior to Visit 1)
- •Unable or unwilling to comply with the protocol, therefore likely to leave the trial before its completion
- •Patient intends to move or to vacation away from home during the course of the study which would interfere with the scheduled visits.
研究组 & 干预措施
1
Experimental
Drug Arm
干预措施: losartan potassium (+) hydrochlorothiazide (Drug)
结局指标
主要结局
Change in Systolic Blood Pressure From Baseline to Week 12
时间窗: Baseline and Week 12
Change in Diastolic Blood Pressure From Baseline to Week 12
时间窗: Baseline and Week 12
次要结局
- Change in Systolic Blood Pressure From Baseline to Week 6(Baseline and Week 6)
- Number of Patients Achieving Target Blood Pressure at Week 12(12 Weeks)
- Change in Uric Acid From Baseline to Week 12(Baseline and Week 12)
- Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6(Baseline and Week 6)
- Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12(Baseline and Week 12)
- Number of Patients Achieving Target Blood Pressure at Week 6(Week 6)
- Time to Achieve Target Blood Pressure(12 weeks)
- Change in Uric Acid From Baseline to Week 6(Baseline and Week 6)
- Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12(Baseline and Week 12)
- Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6(Baseline and Week 6)
- Change in Diastolic Blood Pressure From Baseline to Week 6(Baseline and Week 6)
研究者
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