CTRI/2019/08/020990尚未招募3 期
A Multicentric, Open Label, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 244
- 试验地点
- 15
- 主要终点
- To evaluate the efficacy and safety of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD).
研究概览
简要总结
Ajanta pharma conducting A Multicentric, Open Label, Phase-III ClinicalStudy to Evaluate the Efficacy, Safety (Primary Objective) and Tolerability(Secondary Objective) of Fixed Dose Combination (FDC) of Metoprolol SuccinateER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets andMetoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40mg Tablets in Subjects with uncontrolled essential Hypertension and stablecoronary artery disease (CAD) for 24 weeks in 244 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •To be eligible for the study, Subjects must meet the following criteria: 1.Male or female subjects aged between 18 and 65 years (both inclusive).
- •2.Subjects of stable coronary artery disease (no change in severity of symptoms or nitrate consumption in previous 3 months).
- •3.Subjects with the history of uncontrolled essential hypertension [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 fixed drug combination therapy of Metoprolol Succinate ER (25 mg / 50 mg) plus Telmisartan 40 mg Tablets for at least 4 weeks.
- •4.As judged by the Investigator, based on a medical evaluation performed during the screening period.
- •The medical evaluation must include normal or non-clinically significant physical examination, laboratory examination and 12-lead ECG.
- •6.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 diagnosed with 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.Renal system: 4.1Subjects with abnormal Renal Function Test ( Serum Creatinine Normal range, 0.6 to 1.3 mg/dL) and (BUN Normal range , 7 to 20 mg/dL) 4.2Subjects with abnormal eGFR (less than 60 mL/min/1.73 m2).
- •4.3Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney.
- •4.4Subjects with hyponatremia as per blood biochemistry results at screening (Normal range, 135 to 145 mEq/L).
- •4.5Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening (Normal range, 3.5 to 5.5 mEq/L).
- •5.Hepatic system: 5.1Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
- •6.Endocrine system: 6.1Subjects with abnormal Thyroid Function Test (TSH) (Normal range is 0.45 to 4.5 mIU/mL).
- •6.2Subjects with Type 1 Diabetes Mellitus.
- •6.3Subjects 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%.
- •7.Cardiovascular system: 7.1Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias.
- •7.2Subjects with known case of Stroke.
- •8.Other disease conditions 8.1Subject with clinical history of Bronchospastic disorders.
- •8.2Subjects with medical history of Oncological Conditions since last 2 years.
- •8.3Subjects with known case of Epileptic seizures.
- •8.4Subjects with clinical history of bipolar disorder i.e. who are taking lithium.
- •9.Trial related conditions 9.1Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •9.2Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •9.3Suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
To evaluate the efficacy and safety of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD).
时间窗: Mean change in SeDBP between baseline and 24 weeks | Mean change in SeSBP between baseline and 24 weeks. | The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)].
次要结局
- To evaluate the tolerability of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD).
研究者
研究点 (15)
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