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NCT Number: NCT05416840

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

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.

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Smoking Vascular Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Peking University People's Hospital

Beijing, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • History of cardiopulmonary and vascular disease.
  • Severe liver or kidney disease.
  • Night shift workers, drivers, and those who work at height.

Treatment and study plan

Clonidine controlled-release patch

Drug

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

Drug

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).

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in systolic BP in 24 hour ambulatory BP monitoring (ABPM) from baseline at 8-week

    Time frame: 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.

  2. Between-group differences in smoking cessation rates at 8-week

    Time frame: 8 weeks

    Between-group differences in smoking cessation rates at 8-week in clonidine group and amlodipine are compared

  3. Drug tolerance and adverse effects during 8 weeks of treatment

    Time frame: 8 weeks

    Drug tolerance and adverse effects during 8 weeks of treatment, clonidine or amlodipine, are analyzed

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Liu, MD

CONTACT

[email protected]

01088325457

Sponsors and collaborators

Lead sponsor

Jing Liu

Other

Registry information

Official study title

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

Acronym: ECLIPSE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2022
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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