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临床试验/CTRI/2010/091/000323
CTRI/2010/091/000323招募中4 期

EFFICACY AND TOLERABILITY OF BISOPROLOL IN COMPARISON TO METOPROLOL IN PATIENTS WITH STAGE-I HYPERTENSIO

Investigator (Rajiv KArnik)0 个研究点目标入组 200 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
200

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)Be male or female between the ages 18 to 65 years;
  • 2)New patients (treatment naïve) with diagnosis of stage-I hypertension (SBP 140-159 mm Hg or DBP 90-99 mm Hg);
  • 3)Current physical examination and vital signs at screening that reveals no clinically significant abnormalities;
  • 4)Willing and able to follow the instructions and procedures of the study including 24 hour continuous ambulatory cardiac monitoring;
  • 5)Willing to give written informed consent prior to admission into the study; and
  • 6)If female of childbearing potential, must be using a reliable form of birth control and be willing to continue as such for the duration of the study.

排除标准

  • 1. Confirmed diagnosis of unstable angina;
  • 2. History of Acute Myocardial Infarction (AMI) or cardiac surgery within the preceding 6 months;
  • 3. Has uncompensated congestive heart failure (CHF);
  • 4. Has uncontrolled atrial fibrillation;
  • 5. Having bradycardia defined as a pulse rate below 50 beats per minute;
  • 6. Has bronchial asthma or Chronic obstructive pulmonary disease (COPD);
  • 7. Has Insulin-dependent diabetes mellitus;
  • 8. Have a history suggestive of, or presence of significant, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of study drugs;
  • 9. Have a history of drug or alcohol dependency or psychological disease;
  • 10. Require regular use of medication (other than study medication) that interferes with the absorption and/or metabolism of study drugs (e.g., steroids);
  • 11. Participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study;
  • 12. Have any acute illness within 2 weeks prior to screening;
  • 13. Have known significant hepatic & renal impairment;
  • 14. Subjects who have participated in any clinical trial or use of an investigational drug within 30 days prior to admission to this study;
  • 15. Pregnant or lactating women.

研究者

发起方
Investigator (Rajiv KArnik)

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