A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase III Study of Corever for the Treatment of Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 8
- 主要终点
- Seated Office SBP reduction (SBP each visit-SBP visit 2)
研究概览
简要总结
The study primarily aims to compare the effects of two doses of Corever with placebo in patients with hypertension.
详细描述
The study aims to compare the effects of two doses of Corever with placebo in patients with essential hypertension. Eligible subjects who belong to one of the following subtypes are planned to be enrolled: (1) patients with essential hypertension without drug control, or (2) uncontrolled hypertension despite treatment with up to 2 antihypertensive agents. Of note, the second category will receive randomized study treatments in addition to continuing their previous medication throughout the trial. The study also wants to investigate the safety profile of Corever during treatment period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 20-90 years of age
- •Patients who belong to either one of the following categories:
- •With essential hypertension, as measured by office BP and are not on antihypertensive treatment at screening .
- •With uncontrolled hypertension despite treatment with up to 2 antihypertensive agents, and the type and dose of the agents shall be maintained for at least 28 days prior to entering this trial.
- •Agree to and are able to follow the study procedures.
- •Understand the nature of the study, and have signed informed consent forms.
排除标准
- •Patients with any of the following conditions:
- •Malignant hypertension
- •Secondary hypertension
- •Average sitting SBP ≥ 180 mmHg
- •Advanced hypertensive retinopathy
- •Type 1 diabetes
- •Acute coronary syndrome
- •Clinical significant valvular disease
- •Hypertrophic cardiomyopathies
- •New York Heart Association class III -IV congestive HF
- •Second or third degree atrioventricular block or history of sick sinus syndrome unless a pacemaker is in place
- •Atrial fibrillation
- •Sinus bradycardia (<60 bpm)
- •Stroke within 3 months
- •Cancer with expected survival less than 3 years
- •A difference of > 20 mmHg for SBP or > 10 mmHg for DBP between arms at screening
- •Severe hepatic impairment
- •A history of a serious hypersensitivity reaction.
- •Patients with clinically significant abnormalities.
- •Patients with known contraindication to Corever.
- •Female patients who are pregnant or lactating.
- •Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study.
- •Patients is currently participating in any other clinical trial within 30 days
- •Patients need to be treated with the permitted medication.
研究组 & 干预措施
Corever middle dose
干预措施: Corever (Drug)
Corever high dose
干预措施: Corever (Drug)
Placebo
干预措施: Corever (Drug)
结局指标
主要结局
Seated Office SBP reduction (SBP each visit-SBP visit 2)
时间窗: 8 weeks
To compare the change in office SBP measurements by cuff assessments after 8 weeks of treatment
次要结局
- Seated Office DBP reduction (DBP each visit-DBP visit 2)(8 weeks)