A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety & Tolerability of FDC of Bisoprolol Fumarate plus Telmisartan plus Cilnidipine Tablets versus FDC of Metoprolol Succinate ER plus Telmisartan plus Cilnidipine Tablets in subjects with Stage II Hypertension with Stable Coronary Artery Disease (CAD) not controlled with dual therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 12
研究概览
简要总结
According to recent data, cardiovascular diseases (CVDs) continue to be the leading cause of death and disability in India.1The Global Burden of Disease Study 2019 estimates that CVDs are responsible for a substantial proportion of mortality and disability in the country. In 2020, approximately 2.6 million Indians were reported to die from coronary heart disease (CHD), accounting for a significant percentage of all CVD deaths. Nearly half of these deaths occurred in individuals aged 30-69 years. Indians experience CVD deaths at a younger age compared to their counterparts in high-income countries. Recent estimates suggest that around 52% of CVD deaths in India occur before the age of 70, compared to 23% in high-income countries, highlighting a profound impact on the nation’s economy.2 Key contributing factors include the rising prevalence of hypertension, dyslipidemia, diabetes, obesity, physical inactivity, and tobacco use.
For the same Study Sponsor Revenbhel Healthacre Pvt. Ltd. has developed Fixed-dose combination of Bisoprolol 2.5/5 mg, Cilnidipine 10/10 mg and Telmisartan 40/40 mg tablet which will be compared in the clinical trial against existing approved Fixed-dose combination of Metoprolol ER 50 mg, Cilnidipine 10 mg and Telmisartan 40 mg tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged between 18 to 75 years.
- •Systolic BP (SBP) above or equal to 140 mmHg and diastolic BP (DBP) above or equal to 90 mmHg, despite adherence to a regimen of above or equal to 3 antihypertensive medications, including a diuretic, at optimal doses.
- •Or, SBP above or equal to 160 mmHg and DBP above or equal to 100 mmHg, despite treatment with at least 2 antihypertensive agents.
- •3 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 Simpson’s 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.
- •5.Subjects with eGFR less than 60 mL per min per 1.73m2 Subjects with abnormal lab values of Na+, K+, Mg++, Cl- and Uric acid as per the discretion of the principal investigator.
- •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) or a known case of hepatic cirrhosis.
- •Subjects with abnormal Thyroid Function Test (TSH).
- •Subjects with Type 1 Diabetes Mellitus or 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 percent.
- •Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infraction, percutaneous transluminal coronary angioplasty (PTCA) in less than one year or coronary artery bypass graft (CABG) surgery in 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 significant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.) Subjects with known case of Stroke.
- •9.Subject with clinical history of uncontrolled COPD or Bronchial Asthma.
- •Subjects with medical history of neoplastic disorders with expected survival less than 1 year.
- •Subjects with clinical history of bipolar disorder.
- •10.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 or unwillingness to discontinue them for the entire study period.
- •Suspected inability or unwillingness to comply with the study procedures.
研究者
Sandeep Yadav
Manentia Research Pvt. Ltd