Randomized Open-label Trial to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 992
- 主要终点
- Change in Diastolic Blood Pressure From Baseline to Week 14
研究概览
简要总结
To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; < 221; 140/90 mm Hg But < 180/110 mm Hg)
- •Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure > 180/110 mm Hg but < 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded
- •Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure > 161;< 221; 130/80 mm Hg But < 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure > 161;< 221; 140/90 mm Hg But < 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure > 161;< 221; 130/80 mm Hg But > 161;< 221; 150/90 mm Hg
- •The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug
排除标准
- •Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
- •Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
- •Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
- •Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient
研究组 & 干预措施
Losartan-Based Regimen Alone (L Group)
Losartan-based regimen, with sequential titration including HCTZ and CCB as needed to achieve target blood pressure.
干预措施: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) (Drug)
Diet Management and Losartan-Based Regimen (DML Group)
Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet.
干预措施: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) (Drug)
Diet Management and Losartan-Based Regimen (DML Group)
Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet.
干预措施: Low Salt Diet (Behavioral)
结局指标
主要结局
Change in Diastolic Blood Pressure From Baseline to Week 14
时间窗: 14 Weeks
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
时间窗: 14 Weeks
Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment
Change in Systolic Blood Pressure From Baseline to Week 14
时间窗: 14 Weeks
次要结局
- Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline(6 Weeks)
- Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline(10 Weeks)
- Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline(40 Weeks)
- Change in Systolic Blood Pressure From Baseline to Week 6(6 Weeks)
- Change in Diastolic Blood Pressure From Baseline to Week 6(6 Weeks)
- Change in Systolic Blood Pressure From Baseline to Week 10(10 Weeks)
- Change in Diastolic Blood Pressure From Baseline to Week 10(10 Weeks)
- Time to Achieve the Target Blood Pressure From Baseline(14 Weeks)