A Five-arm, Randomised, Open Label, Multi-centre, Prospective Study to Compare the Efficacy, Safety and Tolerability of Metoprolol XL Plus Amlodipine Combination (Selomax TM) With Metoprolol XL and Amlodipine as Individual Components in Management of Hypertension in Indian Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
研究概览
简要总结
This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation
- •Those who have given their written consent for the study.
排除标准
- •Patients of other forms of hypertension (other than primary)
- •Those who have consistently BP > /=180/120mmHg
- •Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.
- •Patients of diabetes requiring insulin,asthma and kidney diseases.
研究组 & 干预措施
1
FDC of Metoprolol XL 50mg + Amlodipine 5mg
干预措施: Metoprolol XL 50mg + Amlodipine 5mg (Drug)
2
FDC of Metoprolol XL 25mg + Amlodipine 2.5mg
干预措施: Metoprolol XL 25 mg + Amlodipine 2.5mg (Drug)
3
Extended release Metoprolol succinate
干预措施: Metoprolol XL 50mg (Drug)
4
Extended release Metoprolol succinate
干预措施: Metoprolol XL 25 mg (Drug)
5
Amlodipine 5mg in immediate release formulation
干预措施: Amlodipine 5mg (Drug)
结局指标
主要结局
Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
时间窗: 8 weeks
次要结局
- Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.(8 weeks)
- Change in the heart rate,Number of responders & control rates.(8 weeks)
- Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin(8 weeks)