Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients

Chronic Kidney Disease Clinical Trial

— AHOCEP  

Official title:

Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351636
• Other study ID #: DSPC-ALM-1101
• Status: Completed
• Phase: Phase 4
• Start date: April 2011
• Est. completion date: October 10, 2018

Study information

• Verified date: November 2015
• Source: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Arotinolol Hydrochloride
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
• Non arotinolol group
Antihypertensive medications without arotinolol for 18 months

Locations

Country	Name	City	State
China	Nan Chen	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoints		18 months
Secondary	Changes for metabolism related index		18 months
Secondary	Blood pressure control in hypertensive haemodialysis patients		18 months