UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007395 |
|---|---|
| Receipt number | 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 21:31:11 |
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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
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
Sponsor or person
Institute
Clinic Jingumae
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008713
