Clinical trial NCT05416840: Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension
Official title: Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension: a Randomized Controlled Trial (ECLIPSE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hypertension
Keywords: clonidine patch, hypertension, smoking
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in clinic sitting systolic BP from baseline at 8-week
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in systolic BP in 24 hour ambulatory BP monitoring (ABPM) from baseline at 8-week
timeFrame: 8 weeks
measure: Between-group differences in smoking cessation rates at 8-week
timeFrame: 8 weeks
measure: Drug tolerance and adverse effects during 8 weeks of treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jing Liu, MD
role: STUDY_CHAIR
References: