An Open Label, Three Arm, Randomized, Prospective, Multicentric, Phase III Clinical study to evaluate and compare the efficacy and safety of Azilsartan Medoxomil Tablets 20mg, Azilsartan Medoxomil 40mg & Azilsartan Medoxomil 80mg with Telmisartan Tablets 20mg & 40mg in Indian Adults patients of Essential hypertension with or without associated Cardiovascular Complications
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 5
- 主要终点
- Mean reduction in the trough sitting clinic SBP and DBP from baseline to Day 14 (±2) and Day 43(+1)
研究概览
简要总结
Azilsartan medoxomil is an angiotensin II AT1 receptor blocker indicated for the treatment of hypertension to lower the blood pressure. Lowering the blood pressure reduces the risk of fatal and non fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs form a wide variety of pharmacological classes including the class to which this drug primarily belongs. There are no controlled trials demonstrating risk reduction with Azilsartan Medoxomil. Control of high blood pressure should be a part of comprehensive cardiovascular risk management, including, as appropriate lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. Numerous antihypertensive drugs from a variety of pharmacological classes and different mechanisms of action, have been shown in randomized controlled clinical trials to reduce cardiovascular morbidity and mortality. Thus in this study, efficacy and safety of Azilsartam medoxomil 20mg and 40 mg and tablet Azilsartan medoxomil 80 mg will be compared with Telmisartan 20mg and 40 mg tablet in patients with essential hypertension associated with or without cardiovascular complication.
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
- •1.Male or female patients of age between 18-65 years.
- •2.Patients or patient’s legally acceptable representative willing to sign the Informed Consent Form.
- •3.Patients newly diagnosed (first-time diagnosis during screening or within three months before the first day of screening) with Essential Hypertension of Stage 1 with SBP ranging between 140 159 mmHg and / or DBP ranging between 90-99 mmHg. 4.Patients currently: a) on anti-hypertensive drug therapy (for phase A as well as phase B) or b) without anti-hypertensive drug therapy (for phase B only) 5.Female patients of childbearing potential who are sexually active must agree to use adequate contraception, and should neither be pregnant nor lactating from screening throughout the duration of the study 6.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements.
- •7.Patients willing to discontinue current anti-hypertensive drug therapy (if applicable).
排除标准
- •1.Patients (essentially ‘newly diagnosed’) who will be at a significant medical risk arising out of deprivation of regular anti-hypertensive drug treatment during the washout period.
- •2.Patients with a history of chronic kidney disease, renal artery stenosis, excessive aldosterone secretion, pheochromocytoma, or sleep apnea.
- •3.Patients with severe renal impairment (eGFR <60 mL/min/1.73 m2).
- •4.Patients with severe hepatic impairment [SGOT, SGPT and S.
- •Bilirubin (total) ≥1.5 times the upper limit of normal reference values].
- •5.Patients with history of hyperkalemia.
- •6.Patient with known history of unstable cardiovascular disease and/or signiï¬cant cardiac conduction defects.
- •7.Patient with Type 1 or Type 2 Diabetes Mellitus.
- •8.Known history of gout.
- •9.Patients suffering from pre-existing severe cough.
- •10.Patients with history of cardiac surgery in past 3 months prior to screening.
- •11.Known or suspected hypersensitivity to any drug that will be administered during the study.
- •12.Inability to comply with the protocol requirements.
- •13.Participation in any other clinical trial within 3 months of registering in this trial.
- •14.Have any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety of the study drug according to the study protocol.
结局指标
主要结局
Mean reduction in the trough sitting clinic SBP and DBP from baseline to Day 14 (±2) and Day 43(+1)
时间窗: Efficacy: | Baseline to each post randomization visit [Day1, 14, 42 and 43] | Safety: | Each post randomization Visit [Days 1, 7, 14, 28, 42 and 43] | Baseline to each post randomization visit [days 1, 7, 14, 28, 42 and 43]
Safety:
时间窗: Efficacy: | Baseline to each post randomization visit [Day1, 14, 42 and 43] | Safety: | Each post randomization Visit [Days 1, 7, 14, 28, 42 and 43] | Baseline to each post randomization visit [days 1, 7, 14, 28, 42 and 43]
Efficacy:
时间窗: Efficacy: | Baseline to each post randomization visit [Day1, 14, 42 and 43] | Safety: | Each post randomization Visit [Days 1, 7, 14, 28, 42 and 43] | Baseline to each post randomization visit [days 1, 7, 14, 28, 42 and 43]
Percentage of patients reporting AE and/or SAE during the study, its frequency, severity, pattern and causal relationship to the drug.
时间窗: Efficacy: | Baseline to each post randomization visit [Day1, 14, 42 and 43] | Safety: | Each post randomization Visit [Days 1, 7, 14, 28, 42 and 43] | Baseline to each post randomization visit [days 1, 7, 14, 28, 42 and 43]
次要结局
- Change in 24 hour mean (average of all measurements for 24 hours) SBP and DBP.(On day 43 (or 44) as compared to baseline)