NCT01351636

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

April 17, 2019

Status Verified

November 1, 2015

Enrollment Period

7.5 years

First QC Date

May 5, 2011

Last Update Submit

April 15, 2019

Conditions

Chronic Kidney Disease

Keywords

chronic kidney diseasehypertension

Outcome Measures

Primary Outcomes (1)

  • Composite endpoints

    18 months

Secondary Outcomes (2)

  • Changes for metabolism related index

    18 months

  • Blood pressure control in hypertensive haemodialysis patients

    18 months

Study Arms (2)

Arotinolol Hydrochloride

EXPERIMENTAL

Antihypertensive medications plus arotinolol hydrochloride

Drug: Arotinolol Hydrochloride

Non arotinolol group

PLACEBO COMPARATOR

Antihypertensive medications without arotinolol hydrochloride

Drug: Non arotinolol group

Interventions

Arotinolol HydrochlorideDRUG

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

Also known as: Almarl
Arotinolol Hydrochloride
Non arotinolol groupDRUG

Antihypertensive medications without arotinolol for 18 months

Also known as: Control group
Non arotinolol group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nan Chen

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertension

Interventions

arotinololAlmarlControl Groups

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Nan Chen, PhD, MD

    Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2011

First Posted

May 11, 2011

Study Start

April 1, 2011

Primary Completion

October 10, 2018

Study Completion

October 10, 2018

Last Updated

April 17, 2019

Record last verified: 2015-11

Locations

CN(1)