CTRI/2023/07/055818尚未招募4 期
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 - NI
Dr Akshay Ashok Bafna0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •I. Patients of either sex aged between 18 to 75years (both
- •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
- •1. Patients with severe hypertension (defined as a DBP ?120 mmHg
- •or SBP ?180 mmHg)
- •2. Patients with suspected secondary hypertension, heart failure &
- •diagnosed cardiovascular diseases, new cerebrovascular diseases,
- •3. Patients using any other concomitant medications known to affect
- •BP or medication prohibited as per protocol.
- •4. Known hypersensitivity or allergy to calcium channel blockers and
- •angiotensin receptor blockers
- •5. Patients with the history of Bilateral renal artery stenosis, renal
- •artery stenosis
- •in a solitary kidney, patient postâ??renal transplant or with only one
- •functioning
- •6. Patients with history of any other clinically significant uncontrolled
- •diseases such as pulmonary, renal, neurological, psychiatric,
- •gastrointestinal,
- •metabolic, endocrine (uncontrolled diabetes mellitus), immunological
- •hematological disorders or malignancy
- •7. Pregnant or Lactating females; or female patients of childbearing
- •unwilling to use effective contraception
- •8. Those who smoke >1 pack of cigarettes per day
- •9. Patients with continuing history of alcohol and/or drug abuse
- •10. Participation in another clinical trial within 3 months prior to
- •11. Any other reason for which the investigator feels that the patient
- •participate
研究者
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