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
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