Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension: a Randomized Controlled Trial (ECLIPSE)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in clinic sitting systolic BP from baseline at 8-week
研究概览
简要总结
The optimal antihypertensive treatment strategy in young and middle-aged hypertensive adults remains undefined. Clonidine controlled-release patches administered once a week might have the advantage of convenience. ECLIPSE trial is intended to explore the effect and patient tolerability of clonidine controlled-release patches (one patch per week for a total of 8 weeks) in the treatment of hypertension in young and middle-aged adults, compared with long-acting antihypertensive drug amlodipine. Clonidine patch was demonstrated ameliorating the early withdrawal symptoms during smoking cessation. This trial is also intended to observe its effect on smoking cessation in young and middle-aged male smokers.
详细描述
The young and middle-aged hypertensive population is growing, but the optimal antihypertensive treatment strategy remains undefined. Young and middle-aged adults have poor adherence to antihypertensive medications and are prone to missed doses, and weekly formulations may be potentially advantageous. As a centrally acting antihypertensive agent, clonidine exerts sustained antihypertensive effects by agonizing alpha2-adrenoceptors. Clonidine controlled-release patches have the advantage of convenience in that they are administered once a week through a transdermal controlled-release technique to achieve a smooth and sustained action of clonidine. However, there is a lack of evidence from clinical trials on its efficacy and tolerability in the treatment of hypertension in young and middle-aged people. ECLIPSE trial is intended to explore the effect and patient tolerability of clonidine controlled-release patches (one patch per week for a total of 8 weeks) in the treatment of hypertension in young and middle-aged adults, compared with long-acting antihypertensive drug amlodipine. Clonidine patch was demonstrated ameliorating the early withdrawal symptoms during smoking cessation and recommended by American Cancer Society to help people quit smoking. Therefore, this trial is also intended to observe its effect on smoking cessation in young and middle-aged male smokers at the same time.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18-60 years old male with mild hypertension (systolic blood pressure (BP) 140-159 mmHg and/or diastolic BP 90-99 mmHg).
- •History of smoking and a desire to quit.
- •Signed informed consent form.
排除标准
- •History of cardiopulmonary and vascular disease.
- •Severe liver or kidney disease.
- •Night shift workers, drivers, and those who work at height.
研究组 & 干预措施
Clonidine
Patients will receive clonidine controlled-release patch (2.5 mg), once a week
干预措施: Clonidine controlled-release patch (Drug)
Amlodipine
Patients will receive amlodipine (5 mg), once daily
干预措施: Amlodipine (Drug)
结局指标
主要结局
Change in clinic sitting systolic BP from baseline at 8-week
时间窗: 8 weeks
The change in clinic sitting systolic BP from baseline at 8-week in clonidine group and amlodipine group are analyzed, and between groups difference is compared.
次要结局
- Between-group differences in smoking cessation rates at 8-week(8 weeks)
- Drug tolerance and adverse effects during 8 weeks of treatment(8 weeks)
- Change in systolic BP in 24 hour ambulatory BP monitoring (ABPM) from baseline at 8-week(8 weeks)
研究者
Jing Liu
Director of the Department of Hypertension
Peking University People's Hospital