This trial is active, not recruiting.

Condition chronic kidney disease
Treatments arotinolol hydrochloride, non arotinolol group
Phase phase 4
Sponsor Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Start date April 2011
End date September 2017
Trial size 300 participants
Trial identifier NCT01351636, DSPC-ALM-1101


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Antihypertensive medications plus arotinolol hydrochloride
arotinolol hydrochloride Almarl
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
(Placebo Comparator)
Antihypertensive medications without arotinolol hydrochloride
non arotinolol group Control group
Antihypertensive medications without arotinolol for 18 months

Primary Outcomes

Composite endpoints
time frame: 18 months

Secondary Outcomes

Changes for metabolism related index
time frame: 18 months
Blood pressure control in hypertensive haemodialysis patients
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial
Principal investigator Nan Chen, PhD, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Sumitomo Pharmaceutical (Suzhou) Co., Ltd..