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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004949
Receipt No. R000005814
Scientific Title Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Date of disclosure of the study information 2011/02/01
Last modified on 2011/01/25

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Basic information
Public title Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Acronym Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Scientific Title Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Scientific Title:Acronym Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of carvedilol for patients with atrial fibrillation and hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvement of QOL
Key secondary outcomes rate control
cardiovascular event
cardiac function
inflammatory markers
oxidative stress markers

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria permanent atrial fibrillation
hypertension
either out or in hospital follow up
Key exclusion criteria heart failure,severe cardiac dysfunction
high degree atrio-ventricular block,sick sinus syndrome,bradycardia
bronchial asthma
diabetic ketoacidosis,metabolic acidosis
acute myocardial infarction
dialysis patient,severe renal dysfunction
pregnant woman,woman with chance of pregnancy
untreated pheochromocytoma
hypersensitivity to the medicine
a case determined inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kurita
Organization Kinki University School of Medicine
Division name Division of Cardiology,Department of Internal Medicine
Zip code
Address 377-2,Ohno-Higashi,Osaka-Sayama,Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University School of Medicine
Division name Division of Cardiology,Department of Internal Medicine
Zip code
Address
TEL
Homepage URL http://www.med.kindai.ac.jp/rinri/
Email

Sponsor
Institute Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine
Institute
Department

Funding Source
Organization Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2010 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information to evaluate the efficacy and safety of carvedilol

Management information
Registered date
2011 Year 01 Month 25 Day
Last modified on
2011 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005814

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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