Back to resultsEffect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients (AHOCEP)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Arotinolol Hydrochloride
Non arotinolol group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, hypertension
Eligibility Criteria
Inclusion Criteria:
- Aged between 18-75 years-old;
- Chronic kidney disease stage 5 with haemodialysis treatment for 2 months;
- Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks;
- Patients who receiving alfa or beta blockers will be washed out for 2 weeks;
- Written informed consent
Exclusion Criteria:
- Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months;
- Patients who taking class I antiarrhythmic drugs;
- Resting heart rate less than 60;
- Patients with systolic pressure less than 90 mmHg;
- Patients with chronic obstructive pulmonary disease and asthma;
- Patients with cerebral infarction in the last 2 weeks;
- Severe disorders of liver function;
- Allergy to the arotinolol;
- Patients who planning to have kidney transplantation in the near future;
- Pregnancy and breast-feeding;
- Malignant tumor
Sites / Locations
- Nan Chen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arotinolol Hydrochloride
Non arotinolol group
Arm Description
Antihypertensive medications plus arotinolol hydrochloride
Antihypertensive medications without arotinolol hydrochloride
Outcomes
Primary Outcome Measures
Composite endpoints
Secondary Outcome Measures
Changes for metabolism related index
Blood pressure control in hypertensive haemodialysis patients
Full Information
NCT ID
NCT01351636
First Posted
May 5, 2011
Last Updated
April 15, 2019
Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01351636
Brief Title
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients
Acronym
AHOCEP
Official Title
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arotinolol Hydrochloride
Arm Type
Experimental
Arm Description
Antihypertensive medications plus arotinolol hydrochloride
Arm Title
Non arotinolol group
Arm Type
Placebo Comparator
Arm Description
Antihypertensive medications without arotinolol hydrochloride
Intervention Type
Drug
Intervention Name(s)
Arotinolol Hydrochloride
Other Intervention Name(s)
Almarl
Intervention Description
Antihypertensive medications plus arotinolol hydrochloride, dosage of arotinolol hydrochloride from 2.5mg bid, 2 days later increased to 5mg bid or 10mg bid, for 18 months
Intervention Type
Drug
Intervention Name(s)
Non arotinolol group
Other Intervention Name(s)
Control group
Intervention Description
Antihypertensive medications without arotinolol for 18 months
Primary Outcome Measure Information:
Title
Composite endpoints
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Changes for metabolism related index
Time Frame
18 months
Title
Blood pressure control in hypertensive haemodialysis patients
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 18-75 years-old;
Chronic kidney disease stage 5 with haemodialysis treatment for 2 months;
Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks;
Patients who receiving alfa or beta blockers will be washed out for 2 weeks;
Written informed consent
Exclusion Criteria:
Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months;
Patients who taking class I antiarrhythmic drugs;
Resting heart rate less than 60;
Patients with systolic pressure less than 90 mmHg;
Patients with chronic obstructive pulmonary disease and asthma;
Patients with cerebral infarction in the last 2 weeks;
Severe disorders of liver function;
Allergy to the arotinolol;
Patients who planning to have kidney transplantation in the near future;
Pregnancy and breast-feeding;
Malignant tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Chen, PhD, MD
Organizational Affiliation
Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nan Chen
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients
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