临床试验/NCT01294215

NCT01294215已完成3 期

A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension

Bayer0 个研究点目标入组 72 人开始时间: 2011年2月最近更新: 2014年6月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Bayer
入组人数: 72
主要终点: Efficacy changes measured by sitting diastolic blood pressure (DBP)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

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

入选标准

•20 years or older
•Japanese male or female
•Outpatient with essential hypertension
•Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study

排除标准

•Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
•Patients with secondary hypertension or hypertensive emergency

研究组 & 干预措施

Arm 1

Experimental

干预措施: Nifedipine (Adalat, BAYA1040) (Drug)

结局指标

主要结局

Efficacy changes measured by sitting diastolic blood pressure (DBP)

时间窗: Up to 52 weeks

次要结局

Efficacy changes measured by sitting systolic blood pressure (SBP)(Up to 52 weeks)
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines(Up to 52 weeks)
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP(Up to 52 weeks)
Safety variables(Up to 30 days after the last dose of study drug)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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