An Open Label, Single Arm Prospective Study to Evaluate Efficacy and Safety of Losartan Based Therapy Reslio® (Losartan) and Resilo-h® (Losartan+Hydrochlorthiazide) in Diabetic and Uncontrolled Hypertensive Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of Subjects achieving Target Blood Pressure
研究概览
简要总结
To study antihypertensive efficacy of 12 weeks of Losartan based therapy Resilo (Losartan) and Resilo-H (Losartan+ Hydrochlorothiazide) in uncontrolled hypertensive and diabetic hypertensive patients.
详细描述
200 hundred Subjects will be treated with a dose escalation regimen to achieve a target blood pressure. Subjects with mild hypertension at baseline will be started with losartan 50 mgs and those with severe hypertension will be started with losartan H 100/25. After 6 weeks they will titrated if goal blood pressure not achieved. For Mild hypertensive group this will be with losartan H 100/25 and for severe hypertensive group this will by addition of amlodipine 5 mg to regime. Subjects with mild hypertension and diabetes at baseline will be started with losartan H 50/12.5 mg and those with severe hypertension with diabetes will be started with losartan H 100/25. After 6 weeks they will be titrated if goal blood pressure not achieved. For Mild hypertensive-diabetic group this will be with Resilo H 100/25 and for severe hypertensive group this will by addition of amlodipine 5 mg to regime.
Target Blood Pressure is systolic < 140 mmhg and diastolic < 90 mmHg if age < 60 years and systolic < 150 mmHg and diastolic < 90 mmHg if age >60 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign Informed Consent Form.
- •Patients of either sex above 18 years of age.
- •Patients not previously diagnosed with hypertension and with sitting blood pressure > 140/90 mmHg on two readings 15 minutes apart.
- •Newly diagnosed hypertensive patients.
- •Hypertensive patients on other antihypertensive therapies but not at goal
- •Diabetes defined as patient on insulin therapy or oral diabetic therapy or fasting blood glucose on screening > 7 mmol/L
排除标准
- •Patients with history of allergic reaction to any angiotensin II antagonist or a thiazide diuretic
- •Patients with history suggestive secondary hypertension
- •Patients who have taken Resilo or Resilo-H or other losartan based treatment in past three months of study inclusion.
- •Patients with chronic renal failure or who on screening has serum creatinine >150 µmol/L
- •Patients who is participating concurrently in another clinical trial.
研究组 & 干预措施
Mild Hypertensive
Mild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg
干预措施: Losartan 50Mg Tab (Drug)
Mild Hypertensive
Mild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg
干预措施: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET (Drug)
Severe Hypertension
Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg
干预措施: Amlodipine 5mg (Drug)
Mild Hypertensive with Diabetes
Mild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg and diabetes.
干预措施: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET (Drug)
Mild Hypertensive with Diabetes
Mild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg and diabetes.
干预措施: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET (Drug)
Severe Hypertension
Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg
干预措施: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET (Drug)
Severe Hypertension with Diabetes
Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg with diabetes
干预措施: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET (Drug)
Severe Hypertension with Diabetes
Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg with diabetes
干预措施: Amlodipine 5mg (Drug)
结局指标
主要结局
Proportion of Subjects achieving Target Blood Pressure
时间窗: 12 weeks
次要结局
未报告次要终点