A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg) With Placebo for a Treatment Period of 8 Weeks on Ambulatory and Office Cuff Blood Pressure in Postmenopausal Women With Stage 1 or Stage 2 Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 750
- 主要终点
- Mean change in systolic office blood pressure measured at through
研究概览
简要总结
The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have hypertension- Are currently taking antihypertensive medications- Have had natural menopause at least 1 year prior to screening- Must require hormone therapy in the opinion of the investigator
排除标准
- 未提供
研究组 & 干预措施
Arm 1
干预措施: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug)
Arm 3
干预措施: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug)
Arm 4
干预措施: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug)
Arm 5
干预措施: Placebo (Drug)
Arm 2
干预措施: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug)
结局指标
主要结局
Mean change in systolic office blood pressure measured at through
时间窗: After 8 weeks of treatment
Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
时间窗: After 8 weeks of treatment
次要结局
- Mean change in daytime systolic ABPM(After 8 weeks of treatment)
- Mean change in nighttime systolic ABPM(After 8 weeks of treatment)
- Mean change in diastolic blood pressure measured at through(After 8 weeks of treatment)
- Mean changes in 24-hour diastolic ABPM(After 8 weeks of treatment)
- Mean change in daytime diastolic ABPM(After 8 weeks of treatment)
- Mean change in diastolic APBM at through(After 8 weeks of treatment)
- Mean change in nighttime diastolic ABPM(After 8 weeks of treatment)
- Mean change in systolic APBM at through(After 8 weeks of treatment)