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临床试验/CTRI/2011/08/001937
CTRI/2011/08/001937已完成3 期

Comparative Evaluation of Efficacy and Safety of Losartan + Metoprolol XL Combination vs.Losartan + Ramipril Combination in Patients with Essential Hypertension Along with Type II Diabetes - NI

Ipca Laboratories Ltd0 个研究点目标入组 158 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
158

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

  • To be eligible for inclusion, each patient must fulfill each of the following criteria at baseline / randomization:
  • � Patients with study related disease condition.
  • � Patients with essential hypertension
  • � Patients diagnosed of Type II diabetes
  • � The subject must agree to fully comply with study procedures and restrictions.
  • � The subject must willingly give informed consent.

排除标准

  • � Patients with secondary hypertension.
  • � Patients with Type I diabetes mellitus.
  • � Patients with diastolic BP >= 110 mm Hg
  • � Patients with significant cardiovascular disease
  • � Patients with pulmonary diseases
  • � Patients with history of coronary heart disease or any other morbid condition with poor prognosis.
  • � Patients with abnormal renal and liver function
  • � Patients with electrolyte imbalance
  • � Patients with retinopathy or history of retinopathy except non-proliferative retinopathy.
  • � Patients with disease of blood or haematopoetic organs
  • � Patient with known history of diabetic ketoacidosis
  • � Previously diagnosed cases of HIV 1 OR HIV 2, Hepatitis B or C Viruses or syphilis infection.
  • � Patients with use of corticosteroid or chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs).
  • � Patients receiving insulin.
  • � Patients requiring 325 mg/day of aspirin, warfarin sodium, ticlopidine hydrochloride or any other drugs that affecting platelet function and coagulation.
  • � Patient having any concomitant medication, which may interact with action of study drugs.
  • � Patients with known history of hypersensitivity to losartan, metoprolol, ramipril or other similar drugs of same chemical class or any other ingredient of the study formulations or with history of severe allergic disease.
  • � Patients with a history of drug dependence, other substance abuse or excessive alcohol intake on habitual basis or have difficulty in abstaining for the duration of study.
  • � Known intravenous drug abusers
  • � Patients who have used another investigational agent/device or participated in a clinical trial within the last 30 days prior to enrollment
  • � Pregnant or lactating women.
  • � Women of childbearing potential not practicing contraception

研究者

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