CTRI/2010/091/000114已完成3 期
Efficacy and Tolerability of Fixed Dose Combination of Indapamide S.R. (1.5 mg) + Amlodipine (5 mg) in patients suffering from stage II/III hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
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.Newly diagnosed untreated hypertensive patients having a baseline blood pressure > 160/100 mmHg) OR
- •2.Uncontrolled patients of hypertension with a baseline blood pressure > 140/90 mmHg on monotherapy with a Calcium Channel Blocker (CCB)
- •3.Patients of either sex
- •4.With confirmed diagnosis of Stage II/ III (moderate to severe) hypertension, as per JNC 7 guidelines
排除标准
- •1)Uncontrolled diabetes
- •2)H/o myocardial infarction within the previous 3 months
- •3)H/o cerebrovascular event within previous 3 months
- •4)Uncontrolled arrhythmias
- •5)H/o Heart failure
- •6)Patients with severe impaired renal function serum creatinine levels > 5.3 mg/dl and / or serious liver disorders
- •7)Patients unwilling to give informed consent.
- •8)Patients with history of hypersensitivity to Indapamide or Amlodipine
- •9)Any contraindication to Thiazide type diuretic and/or CCB
- •10)Pregnancy or lactation
- •11)Patients with any other condition or disease, which in opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant.
- •12)Patients previously enrolled in similar trial in the last 6 months
研究者
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