Effect of Arotinolol Hydrochloride on Cardiovascular Even... | NCT01351636

Studies
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients

NCT01351636

Sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

300Actual

Phase

Phase 4

Conditions

Chronic Kidney Disease

Interventions

Arotinolol Hydrochloride
Non arotinolol group

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011Actual

Primary Completion Date

Oct 10, 2018Actual

Completion Date

Oct 10, 2018Actual

First Submitted Date

May 5, 2011

First Submission Date that Met QC Criteria

May 10, 2011

First Posted Date

May 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2019

Last Update Posted Date

Apr 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Arotinolol Hydrochloride	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite endpoints		18 months

Secondary Outcomes

Measure	Description	Time Frame
Changes for metabolism related index		18 months
Blood pressure control in hypertensive haemodialysis patients		18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nan Chen, PhD, MD	Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nan Chen		Shanghai	Shanghai Municipality	200025	China

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D006973	Hypertension

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C024523	arotinolol
C094500	Almarl
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided