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

Last updated: January 14, 2024
Sponsor: Jing Liu
Overall Status: Active - Not Recruiting

Phase

4

Condition

Circulation Disorders

Stress

Vascular Diseases

Treatment

Clonidine controlled-release patch

Amlodipine

Clinical Study ID

NCT05416840
20220001
  • Ages 18-60
  • Male

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 Criteria

Inclusion

Inclusion Criteria:

  1. 18-60 years old male with mild hypertension (systolic blood pressure (BP) 140-159 mmHgand/or diastolic BP 90-99 mmHg).
  2. History of smoking and a desire to quit.
  3. Signed informed consent form.

Exclusion

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

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: Clonidine controlled-release patch
Phase: 4
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, 100044
    China

    Site Not Available

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