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

Jing Liu

Status and phase: Not yet enrolling; Phase 4

Conditions: Hypertension

Treatments: Drug: Amlodipine; Drug: Clonidine controlled-release patch

Study type: Interventional

Funder types: Other

Identifiers

NCT05416840

20220001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Clonidine

Experimental group

Description:

Patients will receive clonidine controlled-release patch (2.5 mg), once a week

Treatment:

Drug: Clonidine controlled-release patch

Amlodipine

Active Comparator group

Description:

Patients will receive amlodipine (5 mg), once daily

Treatment:

Drug: Amlodipine