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临床试验/CTRI/2010/091/000114
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

Serdia Pharmaceuticals India Pvt Ltd0 个研究点目标入组 240 人开始时间: 待定最近更新:

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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