跳至主要内容
临床试验/NCT00858702
NCT00858702已完成4 期

Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone

Daiichi Sankyo Co., Ltd.0 个研究点目标入组 105 人开始时间: 2005年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
105
主要终点
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85

研究概览

简要总结

The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
  • Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil

排除标准

  • Patients with secondary hypertension
  • Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

研究组 & 干预措施

1

Experimental

olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks

干预措施: olmesartan medoxomil and a CCB (Drug)

2

Experimental

olmesartan medoxomil and a diuretic tablet (of the thiazide class)

干预措施: olmesartan medoxomil and a diuretic (Drug)

结局指标

主要结局

The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85

时间窗: Baseline to week 8

次要结局

  • Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)(At week 8)
  • Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)(At week 8)

研究者

申办方类型
Industry

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