A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets versus FDC of Metoprolol Succinate ER 50 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 16
- 主要终点
- To evaluate the efficacy and safety of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease
研究概览
简要总结
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets versus FDC of Metoprolol Succinate ER 50 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease.
Primary Objective: To evaluate the efficacy and safety of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease.
Secondary Objective: To evaluate the tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects aged between 18 and 65 years.
- •2.Subjects with the history of uncontrolled essential hypertension with stable ischemic heart disease [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable doses of Metoprolol Succinate ER 25 mg plus Telmisartan 40 mg Tablets for at least 4 weeks.
- •3.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
- •4.Female subjects of childbearing potential must be willing to use acceptable method of contraception or post-menopausal for at least one year or surgically sterile.
排除标准
- •Subjects with any of the following conditions will be excluded from the study: 1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •2.Subjects with diagnosed Secondary or Malignant Hypertension.
- •3.Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
- •4.Cardiovascular system, Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias.
- •Subject who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year.
- •Subjects with known case of stroke.
结局指标
主要结局
To evaluate the efficacy and safety of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease
时间窗: at the end of 12 weeks
次要结局
- To evaluate the tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease(at the end of 12 weeks)