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

Hypertension Clinical Trial

— ECLIPSE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05416840
• Other study ID #: 20220001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2024
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Peking University People's Hospital
• Contact: Jing Liu, MD
• Phone: 01088325457
• Email: heartcenter[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: December 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 18-60 years old male with mild hypertension (systolic blood pressure (BP) 140-159 mmHg and/or diastolic BP 90-99 mmHg).

2. History of smoking and a desire to quit.

3. Signed informed consent form.

Exclusion Criteria:

1. History of cardiopulmonary and vascular disease.

2. Severe liver or kidney disease.

3. Night shift workers, drivers, and those who work at height.

Related Conditions & MeSH terms

• Hypertension

Intervention

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).
• 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).

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jing Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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