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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02545530
Other study ID # KLD2015.0203
Secondary ID
Status Recruiting
Phase N/A
First received September 4, 2015
Last updated September 7, 2015
Start date May 2015
Est. completion date May 2016

Study information

Verified date September 2015
Source Peking University People's Hospital
Contact Li ZUO, MD
Phone +861088324008
Email zuolimd@hotmail.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The majority of chronic hemodialysis patients need a combination of several antihypertensive drugs for adequate BP control. The primary objective of this study is to evaluate whether transdermal clonidine can improve blood pressure control or decrease oral antihypertensive agents type or dosage and the secondary objective is to observe incidence of adverse reactions of transdermal clonidine in chronic hemodialysis patients.


Description:

It's a randomised crossover clinical trial. Subjects: chronic hemodialysis patients. All subjects will be randomised to 2 groups. Subjects in first group will receive 4 weeks transdermal clonidine plus regular antihypertensive agents treatments first, 2weeks wash-out then and 4 weeks antihypertensive agents without transdermal clonidine. The other group will receive 4 weeks antihypertensive agents without transdermal clonidine first, 2weeks wash-out then and 4 weeks transdermal clonidine plus regular antihypertensive agents treatments. Ambulatory blood pressure, echocardiography, and biochemistry will be detected.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. signed informed consent;

2. age: 18years to 80 years old;

3. on hemodialysis for more than or equal to 3 months, not less than 3 times and 12 hours hemodialysis per week;

4. cardiac function grade I or grade II(NYHA);

5. Using 1 or more than 1 oral antihypertensive drugs, pre-dialysis systolic blood pressure over 140mmHg or dialysis blood pressure over 90mmHg, post-dialysis systolic blood pressure over 130mmHg or diastolic blood pressure over 80mmHg

Exclusion Criteria:

1. acute infection within 1 month;

2. acute myocardial infarction/cardiac function grade IV/stroke within 3months;

3. LVEF lower than 50% by echocardiography;

4. Dry weight is not suitable by BCM evaluation, more than plus or minus 1kg;

5. Inter-dialysis weight gain exceeds 5% of dry weight;

6. Post-dialysis systolic blood pressure lower than 120mmHg and diastolic blood pressure lower than 70mmHg;

7. Begin or stop recombinant human erythropoietin treatment within 2 weeks before inclusion or 10 weeks after inclusion;

8. Adjust recombinant human erythropoietin dosage to more than 2times or less than half original dosage within 2 weeks before inclusion or 10 weeks after inclusion;

9. The treatment regimen will be amended within 10 weeks and it is expected that the treatment amendment may affect blood pressure;

10. Pregnancy or lactation or planning a pregnancy in 10 weeks;

11. Expected to withdraw hemodialysis treatment in 10 weeks;

12. Allergic to clonidine or its accessories;

13. Undergoing other clinical studies, and the research interventions have an impact on blood pressure;

14. Other clinical conditions that may affect the results

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
transdermal clonidine
2.5mg/patch per week

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes of blood pressure and oral antihypertensive agents' dosage and type mmHg of MAP decreased, changes of total antihypertensive agents' DDD and changes of total antihypertensive agents' types 4 weeks No
Secondary incidence of adverse effects compared with control group 4 weeks Yes
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