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

Condition(s) studied

Investigational drug(s) / intervention(s)

Clonidine controlled-release patch: 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).

Amlodipine: 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).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in clinic sitting systolic BP from baseline at 8-week — 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.

Trial sites (1)

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