Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 5, 2011
February 19, 2013
April 2011
April 2014   (final data collection date for primary outcome measure)
Composite endpoints [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Rate of mortality and cardiovascular events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01351636 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Kidney Disease
  • Drug: Arotinolol Hydrochloride
    2.5mg bid,2 days later increased to 5mg bid or 10mg bid, for 18 months
    Other Name: Almarl
  • Drug: Non arotinolol group
    Antihypertensive medications without arotinolol for 18 months
  • Experimental: Arotinolol
    Intervention: Drug: Arotinolol Hydrochloride
  • Placebo Comparator: Non arotinolol group
    Intervention: Drug: Non arotinolol group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
China
 
NCT01351636
DSPC-ALM-1101
Yes
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Not Provided
Principal Investigator: Nan Chen, PhD, MD Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP