A Prospective, Randomized, Open label, Investigator Initiated academic clinical trial to evaluate theefficacy and safety of FDC of Azelnidipine and Telmisartan as compared to FDC of Amlodipine andTelmisartan in Indian Essential Hypertensive Patients
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- two groups
研究概览
简要总结
This study is Prospective, Randomized, Open label, Investigator Initiated academic clinical trial to evaluate the efficacy and safety of FDC of Azelnidipine (16 mg)and Telmisartan (40 mg) as compared to FDC of Amlodipine (5 mg) and Telmisartan (40 mg) in Indian Essential Hypertensive Patients daily for 12 weeks to evaluate the safety and efficacy between two groups. The primary endpoint of the study is to evaluate the change in seated office blood pressure from baseline (Week 0) to end of 12 weeks in two groups. The secondary endpoints of the study are proportion of patients achieving the normal blood pressure (SBP<120 and DBP<80 mmHg) at end of week 4 & 12, Change in pulse rate from baseline to end of 4 & 12 weeks and change in UACR from baseline to end of 12 weeks in two groups. For safety number of Adverse events and serious adverse events reported during the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged between 18 to 75years (both inclusive) II.
- •Treatment Naïve hypertensive patients with stage II hypertension or patients who are not controlled on Telmisartan monotherapy (40 mg) with Stage I or II hypertension III.
- •Patients willing to provide written informed consent and comply with the protocol requirements IV.
- •Subjects having no abnormalities in general physical examination.
排除标准
- •Patients with severe hypertension (defined as a DBP ?120 mmHg or SBP ?180 mmHg)
- •Patients with suspected secondary hypertension, heart failure & diagnosed cardiovascular diseases, new cerebrovascular diseases,
- •Patients using any other concomitant medications known to affect BP or medication prohibited as per protocol.
- •Known hypersensitivity or allergy to calcium channel blockers and angiotensin receptor blockers
- •Patients with the history of Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patient post–renal transplant or with only one functioning kidney
- •Patients with history of any other clinically significant uncontrolled systemic diseases such as pulmonary, renal, neurological, psychiatric, gastrointestinal, metabolic, endocrine (uncontrolled diabetes mellitus), immunological or hematological disorders or malignancy
- •Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •Those who smoke >1 pack of cigarettes per day
- •Patients with continuing history of alcohol and/or drug abuse
- •Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
two groups
时间窗: 12 Weeks
Change in seated office blood pressure (SBP &
时间窗: 12 Weeks
DBP) from baseline to end of 12 weeks in the
时间窗: 12 Weeks
次要结局
- For Efficacy; Propotion of patients achieving(normal blood pressure (SBP120 and)
- For Safety numbers of Adverse events & Serious(adverse events reported during the study.)