Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension

Study Overview
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Brief Summary
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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 observe 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.

Detailed Description
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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 observe 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. Therefore, this trial is also intended to observe its effect on smoking cessation in young and middle-aged male smokers at the same time.

Official Title
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Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension: a Randomized Controlled Trial (ECLIPSE)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Clonidine controlled-release patch
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Moderate or severe hypertension (systolic BP/diastolic BP >= 160/100 mmHg). History of cardiopulmonary and vascular disease. Severe liver or kidney disease. Night shift workers, drivers, and those who work at height.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clonidine<br>Patients will receive clonidine controlled-release patch (2.5 mg), once a week | Drug: Clonidine controlled-release patch<br>* Enrolled patients receive clonidine patch (2.5 mg), once a week. The doses are doubled, if the office systolic BP not at goal (<140 mmHg) at 4 weeks. All patients receive smoking cessation advice at the beginning, and smoking cessation promotion information is pushed by WeChat three times during the observation period (weeks 2, 4 and 6).<br>|
| Active Comparator: Amlodipine<br>Patients will receive amlodipine (5 mg), once daily | Drug: Amlodipine<br>* Enrolled patients receive amlodipine (5 mg), once daily. The doses are doubled, if the office systolic BP not at goal (<140 mmHg) at 4 weeks. All patients receive smoking cessation advice at the beginning, and smoking cessation promotion information is pushed by WeChat three times during the observation period (weeks 2, 4 and 6).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinic sitting systolic BP from baseline at 8-week | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic BP in 24 hour ambulatory BP monitoring (ABPM) from baseline at 8-week | The change in systolic BP in 24 hour ambulatory BP monitoring (ABPM) from baseline at 8-week in clonidine group and amlodipine group are analyzed, and between groups differences are compared. | 8 weeks | 
| Between-group differences in smoking cessation rates at 8-week | Between-group differences in smoking cessation rates at 8-week in clonidine group and amlodipine are compared | 8 weeks | 
| Drug tolerance and adverse effects during 8 weeks of treatment | Drug tolerance and adverse effects during 8 weeks of treatment, clonidine or amlodipine, are analyzed | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clonidine patch, hypertension, smoking