Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients

NCT ID: NCT01351636

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-10-10

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arotinolol Hydrochloride

Antihypertensive medications plus arotinolol hydrochloride

Group Type: EXPERIMENTAL

Arotinolol Hydrochloride

Intervention Type: DRUG

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 hydrochloride

Group Type: PLACEBO_COMPARATOR

Non arotinolol group

Intervention Type: DRUG

Antihypertensive medications without arotinolol for 18 months

Interventions

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

Intervention Type: DRUG

Non arotinolol group

Antihypertensive medications without arotinolol for 18 months

Intervention Type: DRUG

Other Intervention Names

Almarl; Control group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nan Chen, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital

Locations

Nan Chen

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

DSPC-ALM-1101

Identifier Type: -

Identifier Source: org_study_id