NCT05416840

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Jing Liu · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	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).
DRUG	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).

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2022-06-13
• Last updated: 2024-01-17

Locations

1 site across 1 country: China