CTRI/2017/12/010961已完成3 期
A Double Blind, Randomized, Multicentric, Active Controlled, Parallel group,Comparative Phase III study to evaluate the Efficacy and Safety of fixed dose combination of Azilsartan medoxomil and Chlorthalidone versus fixed dose combination of Olmesartan medoxomil and Hydrochlorothiazide in patients with moderate to severe hypertension
SYNOKEM Pharmaceuticals Limited0 个研究点目标入组 306 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 306
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Men and women between 18-65 years of age (Both are inclusive).
- •2. Newly diagnosed patients or De novo patients are eligible for study.
- •3. Patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
- •4. Patient having moderate to severe systolic hypertension (defined as sitting trough clinic systolic blood pressure is between 160 mmHg and 190 mmHg inclusive at screening visit)
- •5. Patients with sitting diastolic hypertension (DBP) <119 mmHg at screening visit
- •6. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
- •7. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator
排除标准
- •1. Clinically significant renal (estimated glomerular filtration rate: <30 mL/min per 1.73 m2) metabolic, hepatic, or psychiatric disorders.
- •2. Hypersensitive to angiotensin II receptor blockers or diuretics or any ingredient of the formulation.
- •3. Recent history (within the last 6 months) of myocardial infarction, Patients with NYHA class III and IV heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
- •4. Clinically relevant or unstable cardiovascular diseases
- •5. Type 1 or poorly controlled type 2 diabetes mellitus (HbA1c: ââ?°Â¥ 8%).
- •6. Pregnant, nursing women or women with childbearing potential not using medically approved means of contraception
- •7. Patients taking any antihypertensive or concomitant medications known to affect BP.
- •8. History of drug or alcohol abuse or those who smoke >1 pack of cigarettes per day
- •9. Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study.
- •10. Secondary hypertension of any etiology.
- •11. Subject who have used any investigational drug or device within 30 days or 5 half-lives of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.
- •12. Any other disease state which could interfere with trial participation or trial evaluation as per investigatorââ?¬Å¸s discretion
研究者
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