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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Sumitomo Pharmaceutical (Suzhou) Co., Ltd..
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 September 30, 2014