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

This study is currently recruiting participants.
Verified May 2011 by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01351636
First received: May 5, 2011
Last updated: February 19, 2013
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
 Drug: Arotinolol Hydrochloride
Drug: Non arotinolol group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:

Primary Outcome Measures:
  • Composite endpoints [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes for metabolism related index [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Blood pressure control in hypertensive haemodialysis patients [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arotinolol Drug: Arotinolol Hydrochloride
2.5mg bid,2 days later increased to 5mg bid or 10mg bid, for 18 months
Other Name: Almarl
Placebo Comparator: Non arotinolol group Drug: Non arotinolol group
Antihypertensive medications without arotinolol for 18 months

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351636

Locations
China, Shanghai
Nan Chen Recruiting
Shanghai, Shanghai, China, 200025
Contact: Nan Chen, PhD, MD     86-21-64370045 ext 665232     chen-nan@medmail.com.cn    
Principal Investigator: Nan Chen, Ph D, MD            
Sponsors and Collaborators
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Investigators
Principal Investigator: Nan Chen, PhD, MD Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital
  More Information

No publications provided

Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01351636     History of Changes
Other Study ID Numbers: DSPC-ALM-1101
Study First Received: May 5, 2011
Last Updated: February 19, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:
chronic kidney disease
hypertension

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Arotinolol
Adrenergic alpha-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Antagonists

ClinicalTrials.gov processed this record on May 23, 2013