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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007395
Receipt No. R000008713
Scientific Title The effect of combination therapy with anti-hypertensive drugs on central blood pressure
Date of disclosure of the study information 2012/03/01
Last modified on 2013/02/11

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Basic information
Public title The effect of combination therapy with anti-hypertensive drugs on central blood pressure
Acronym The effect of combination therapy with anti-hypertensive drugs on central blood pressure
Scientific Title The effect of combination therapy with anti-hypertensive drugs on central blood pressure
Scientific Title:Acronym The effect of combination therapy with anti-hypertensive drugs on central blood pressure
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of olmesartan combined with either azelnidipine or amlodipine on central blood pressure in hypertensive patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Central Blood Pressure
Echocardiography
Key secondary outcomes Augmentation Index
Brachial-Ankle Pulse Wave Velocity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olmesartan/Azelnidipine
Interventions/Control_2 Olmesartan/Amlodipine
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
36 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with brachial SBP>=140 mmHg and/or DBP>= 90 mmHg received olmesartan monotherapy (20 mg daily) for 12 weeks
Key exclusion criteria 1) secondary hypertension
2) arrhythmia
3) current treatmentfor congestive
heart failure
4) a history of stroke or coronary
artery disease
5) clinically significant valvular heart
disease
6) renal insufficiency
(serum creatinine >=2mg/dL)
7) mental disorders
severe noncardiovascular disease
8) chronic inflammatory disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Takami
Organization Clinic Jingumae
Division name Internal Medicine
Zip code
Address 5-4-41 Naizencho Kashihara
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Clinic Jingumae
Division name Internal Medicine
Zip code
Address 5-4-41 Naizencho Kashihara
TEL
Homepage URL
Email

Sponsor
Institute Clinic Jingumae
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 03 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 Treatment with olmesartan/azelnidipine for 2 years resulted in greater improvements in central blood pressure, left ventricular mass index, left ventricular diastolic function, and arterial stiffness compared with olmesartan/amlodipine.
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 Completed
Date of protocol fixation
2006 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2012 Year 01 Month 10 Day
Date of closure to data entry
2012 Year 01 Month 10 Day
Date trial data considered complete
2012 Year 02 Month 03 Day
Date analysis concluded
2012 Year 03 Month 05 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 28 Day
Last modified on
2013 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008713

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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