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

Phase 4

Not yet recruiting

• Conditions: Hypertension
• Interventions: Drug: Clonidine controlled-release patch; Drug: Amlodipine

• Registration Number: NCT05416840
• Lead Sponsor: Jing Liu

Brief 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.

Study Timeline

• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-13
• Status Verified: 2024-01
• Study Start: 2024-01
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonidine	Clonidine controlled-release patch	Patients will receive clonidine controlled-release patch (2.5 mg), once a week
Amlodipine	Amlodipine	Patients will receive amlodipine (5 mg), once daily

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Between-group differences in smoking cessation rates at 8-week	8 weeks	Between-group differences in smoking cessation rates at 8-week in clonidine group and amlodipine are compared
Drug tolerance and adverse effects during 8 weeks of treatment	8 weeks	Drug tolerance and adverse effects during 8 weeks of treatment, clonidine or amlodipine, are analyzed
Change in systolic BP in 24 hour ambulatory BP monitoring (ABPM) from baseline at 8-week	8 weeks	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.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China