Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients (AHOCEP)

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Sumitomo Pharma

Status and phase

Completed
Phase 4

Conditions

Chronic Kidney Disease

Treatments

Drug: Non arotinolol group
Drug: Arotinolol Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01351636
DSPC-ALM-1101

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups, including a placebo group

Arotinolol Hydrochloride
Experimental group
Description:
Antihypertensive medications plus arotinolol hydrochloride
Treatment:
Drug: Arotinolol Hydrochloride
Non arotinolol group
Placebo Comparator group
Description:
Antihypertensive medications without arotinolol hydrochloride
Treatment:
Drug: Non arotinolol group

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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