CTRI/2020/03/023708已完成3 期
A Phase III Randomized, Double blind, Parallel Group Comparative Clinical Trial to Evaluate the safety, tolerability and efficacy of 2 Fixed dose combinations of Azelnidipine and Chlorthalidone when compared with fixed dose combination of Amlodipine and Hydrochlorothiazide in patients with Stage II hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- The safety and tolerability of the FDCs will be assessed by the Clinical AEs, including laboratory abnormalities
研究概览
简要总结
Hypertension (HTN) is a public health menace contributing up to 45% of cardiovascular diseases (CVD) deaths and 51% of stroke deaths. [1] In India up to 33% of urban and 25% of the rural population are afflicted with the disease. [2]
Attainment of blood pressure (BP) goals in the population at large is a major challenge and area of focus of health systems worldwide. Over the years, BP targets have been continuously redefined as the armamentarium of drugs has expanded. The recently published the American College of Cardiology/American Heart Association (ACC/AHA) 2017 HTN guidelines advocate a paradigm shift in the way we manage abnormal BP.
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
- •Male or female subjects aged between 18 and 65 years (both inclusive).
- •2.Treatment naïve subjects diagnosed with stage 2 hypertension having mean seated SBP of ≥160 to ≤180 mmHg and mean seated DBP ≥100 to ≤110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min.
- •rest and subsequent two readings will be recorded at the interval of 2 min.
- •Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •4.Subjects willing to comply with the protocol requirements.
排除标准
- •1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •2.Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
- •Subjects with known case of Secondary or Malignant Hypertension.
- •4.Subjects with evidence of postural hypotension (defined as drop in >20 mmHg for systolic blood pressure and >10 mmHg for diastolic blood pressure after assuming the standing posture from supine or sitting position).
- •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.
- •7.Subjects with known case of Stroke.
- •8.Subjects with abnormal eGFR (<60 mL/min/1.73 m2).
- •9.Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney.
- •Subjects with hyponatremia as per blood biochemistry results at screening.
- •Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening.
- •Subjects with abnormal Liver Function Tests (Total bilirubin, SGOT & SGPT) with values more than 2.5 times the upper limit of normal.
- •13.Subjects with abnormal Thyroid Function Test (TSH).
- •14.Subjects with Type 1 diabetes & Type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
- •15.Subjects with medical history of Oncological Conditions since last 5 years.
- •16.Subjects with known case of Epileptic seizures.
- •17.Subjects with clinical history of bipolar disorder.
- •18.Subjects with known case of HIV, Hepatitis B & C.
- •19.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •21.Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •22.Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •23.Suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
The safety and tolerability of the FDCs will be assessed by the Clinical AEs, including laboratory abnormalities
时间窗: Day 1, Week 2, Week 4, Week 8 and Week 12
次要结局
- 1.Difference in mean change in SBP from baseline at the end of 12 weeks between each FDC group(2.Difference in mean change in DBP from baseline at the end of 12 weeks between each FDC group)
研究者
研究点 (6)
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