NCT05416840

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
7mo left

Started Jan 2024

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

June 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

June 9, 2022

Last Update Submit

January 14, 2024

Conditions

Hypertension

Keywords

clonidine patch, hypertension, smoking

Outcome Measures

Primary Outcomes (1)

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

    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.

    8 weeks

Secondary Outcomes (3)

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

    8 weeks

  • Between-group differences in smoking cessation rates at 8-week

    8 weeks

  • Drug tolerance and adverse effects during 8 weeks of treatment

    8 weeks

Study Arms (2)

Clonidine

EXPERIMENTAL

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

Drug: Clonidine controlled-release patch

Amlodipine

ACTIVE COMPARATOR

Patients will receive amlodipine (5 mg), once daily

Drug: Amlodipine

Interventions

Clonidine controlled-release patchDRUG

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).

Clonidine
AmlodipineDRUG

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).

Amlodipine

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale smokers with mild hypertension
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

HypertensionSmoking

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jing Liu, MD

    Peking University People's Hospital

    STUDY CHAIR

Central Study Contacts

Jing Liu, MD

CONTACT

01088325457heartcenter@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Department of Hypertension

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 13, 2022

Study Start

January 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)