A Multicentric, Randomized, Double Blind, Double-Dummy, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Telmisartan 40/40 mg plus Amlodipine 5/5 mg plus Bisoprolol 2.5/5 mg tablets Versus Co-administration of Telmisartan 40 mg tablets, Amlodipine 5 mg tablets and Bisoprolol 5 mg tablets in subjects with Uncontrolled Essential Hypertension with stable coronary artery disease (CAD).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 9
- 主要终点
- Mean change in SeSBP from baseline to end of study.
研究概览
简要总结
It is a Multicentric, Randomized, Double Blind, Double-Dummy, Parallel Group, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of Telmisartan 40/40 mg plus Amlodipine 5/5 mg plus Bisoprolol 2.5/5 mg tablets Versus Co-administration of Telmisartan 40 mg tablets, Amlodipine 5 mg tablets and Bisoprolol 5 mg tablets in subjects with Uncontrolled Essential Hypertension with stable coronary artery disease (CAD).
The primary objective of the study is to evaluate the efficacy of FDC of Telmisartan 40/40 mg plus Amlodipine 5/5 mg plus Bisoprolol 2.5/5 mg tablets in subjects with Uncontrolled Essential Hypertension with stable coronary artery disease (CAD).
The secondary objective of the study is to evaluate the safety and tolerability of FDC of Telmisartan 40/40 mg plus Amlodipine 5/5 mg plus Bisoprolol 2.5/5 mg tablets in subject with Uncontrolled Essential Hypertension with stable coronary artery disease (CAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged between 18 and 75 years.
- •Subjects of stable coronary artery disease.
- •Subjects with the history of uncontrolled essential hypertension with stable coronary artery disease [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable dose of Amlodipine 5 mg plus Bisoprolol 5 mg Tablets for at least 4 weeks.
- •Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •Subjects with EF less than 40 percent on as per Simpsons method on 2D Echo.
- •Subjects diagnosed with Malignant Hypertension.
- •Surgical or medical condition that, in the judgment of the Investigator, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
- •Renal system: Subjects with eGFR less than 60 mL/min/1.73m2 Subjects with abnormal lab values of Na+, K+, Mg++, Cl- and Uric acid.
- •Normal range: Na+ = 135-145 mEq/L, K+ = 3.5-5.0 mmol/L, Mg++ = 1.8-2.2 mg/dL, Cl-= 96-106 mEq/L and Uric acid 3.5-7.2 mg/dL.
- •Hepatic system: Subjects with abnormal AST, ALT and alkaline phosphate with values more than 2.5 times the upper limit of normal, Bilirubin greater than 1.5 times upper limit of normal (ULN)/ Known hepatic cirrhosis).
- •Endocrine system: Subjects with abnormal Thyroid Function Test [Normal range TSH = 0.4 to 4.0 mIU/L, T4 = 0.8 to 2.8 ng/dL, T3 = 100 to 200 nanograms per deciliter (ng/dL)].
- •Subjects with Type 1 Diabetes Mellitus / Diabetes Insipidus.
- •Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
- •Cardiovascular system: Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infraction, percutaneous transluminal coronary angioplasty (PTCA) less than one year or coronary artery bypass graft (CABG) surgery less than one year, sinus node dysfunction, and any history of bradyarrhythmia and any clinically significant cardiac arrhythmias.
- •Any known cardiac disease/disorder in which any of the study medication is contra- indicated (e.g. severe bradycardia, heart block greater than a first degree or signific ant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.) Subjects with known case of Stroke.
- •Subject with clinical history of Peripheral Vascular disease.
- •Subjects with medical history of neoplastic disorders with expected survival less than 1 year.
- •Subjects with clinical history of bipolar disorder.
- •Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •Suspected inability or unwillingness to comply with the study procedures.
- •Female subjects of childbearing potential not be willing to use an acceptable method of contraception.
- •Pregnant woman or lactating mother.
结局指标
主要结局
Mean change in SeSBP from baseline to end of study.
时间窗: Mean change in SeSBP from baseline to end of study (12 weeks). | Mean change in SeDBP from baseline to end of study (12 weeks).
Mean change in SeDBP from baseline to end of study.
时间窗: Mean change in SeSBP from baseline to end of study (12 weeks). | Mean change in SeDBP from baseline to end of study (12 weeks).
次要结局
- Proportion of patients achieving SeSBP.(Proportion of patients achieving SeDBP.)
研究者
Dr Ujwala Salvi
Nucleon Research Pvt. Ltd.