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Trial record 23 of 326 for:    clonidine

Transdermal Clonidine in Chronic Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT02545530
Recruitment Status : Unknown
Verified September 2015 by Li Zuo, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : September 10, 2015
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Li Zuo, Peking University People's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Dialysis Drug: transdermal clonidine Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transdermal Clonidine on Blood Pressure of Chronic Hemodialysis Patients: A Randomized Crossover Clinical Trial
Study Start Date : May 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: transdermal clonidine+
apply one transdermal clonidine(2.5mg) each week for 4 weeks besides regular antihypertensive agents, reduce oral antihypertensive agents' dosage or type if blood pressure decreased.
Drug: transdermal clonidine
2.5mg/patch per week

No Intervention: transdermal clonidine-
regular antihypertensive treatment



Primary Outcome Measures :
  1. changes of blood pressure and oral antihypertensive agents' dosage and type [ Time Frame: 4 weeks ]
    mmHg of MAP decreased, changes of total antihypertensive agents' DDD and changes of total antihypertensive agents' types


Secondary Outcome Measures :
  1. incidence of adverse effects compared with control group [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545530


Contacts
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Contact: Li ZUO, MD +861088324008 zuolimd@hotmail.com
Contact: Liangying Gan, MD +861088324005 ganl@bjmu.edu.cn

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Li Zuo, MD    +861088324008    zuolimd@hotmail.com   
Contact: Liangying Gan, MD    +861088324005    Ganl@bjmu.edu.cn   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Li Zuo, MD Peking University People's Hospital

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Responsible Party: Li Zuo, Head of department of nephrology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02545530     History of Changes
Other Study ID Numbers: KLD2015.0203
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015
Keywords provided by Li Zuo, Peking University People's Hospital:
renal dialysis
hypertension
clonidine
Additional relevant MeSH terms:
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Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action