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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002631
Receipt No. R000003205
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of olmesartan and amlodipine on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases
Date of disclosure of the study information 2009/10/16
Last modified on 2011/12/01

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Basic information
Public title Prospective, randomized, open-label, clinical trial comparing the effects of olmesartan and amlodipine on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases
Acronym Prospective, randomized, open-label, clinical trial comparing the effects of olmesartan and amlodipine
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of olmesartan and amlodipine on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases
Scientific Title:Acronym Prospective, randomized, open-label, clinical trial comparing the effects of olmesartan and amlodipine
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of olmesartan versus amlodipine on blood pressure, endothelial function and levels of markers for inflammation/obesity/oxidative stress/early stage kidney diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure (On visit/Home monitoring)
Flow-mediated vasodilation in forearm
Heparin-releasable EC-SOD levels
Twelve weeks after administration
Key secondary outcomes Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria)
Twelve weeks after administration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Administration of olmesartan
Interventions/Control_2 Administration of 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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Hypertensive patients recommended for administration of antihypertensive agents in Hypertension Guidelines issued by Japanese Association of Hypertension
2) Outpatients
3) Subjects who gave written informed consent
Key exclusion criteria 1) Allergy against olmesartan/amlodipine
2) Poor-controlled hypertension (DBP>110 mmHg)
3) Poor-controlled diabetes (HbA1c>8.0 %)
4) Secondary hypertension
5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
6) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits.
7) End stage renal disease
8) Symptomatic (NYHA III or IV) congestive heart failure
9) Malignancies or other diseases with poor prognosis
10) Pregnant
11) Subjects whose doctor in charge do not agree to join the trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsunori Ikewaki
Organization National Defense Medical College
Division name Department of Internal Medicine
Zip code
Address 3-2 Namiki, Tokorozawa Japan 359-8513
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ayaori
Organization National Defense Medical College
Division name Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email ayaori@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nature.com/hr/journal/v34/n6/full/hr201111a.html
Number of participants that the trial has enrolled
Results
Endothelial dysfunction in essential hypertension is an independent predictor for future cardiovascular events. Although inhibition of the renin-angiotensin system (RAS) reportedly improves endothelial function through its effects on oxidative stress and inflammation, questions remain regarding which factors are pivotal for improvement of endothelial function by RAS inhibition. We therefore performed a prospective, randomized crossover trial in which an angiotensin II type 1 receptor antagonist (ARB), olmesartan, and calcium channel blocker (CCB), amlodipine, were compared in 31 essential hypertensive patients. Results showed that, although both treatments achieved comparable lowering of blood pressure (BP), olmesartan, but not amlodipine, significantly improved endothelial function as evaluated by flow-mediated vasodilation (FMD) in the brachial artery. Although no significant changes in diabetic and lipid parameters were observed with either drug, olmesartan slightly decreased estimated glomerular filtration rate which, surprisingly, translated into decreased microalbuminuria. In a similar vein, olmesartan reduced serum C-reactive protein and increased urine antioxidant levels compared to baseline, and reduced urine 8-epi-prostaglandin F2alpha levels compared to both baseline and amlodipine. Finally, although overall changes in plasma extracellular superoxide dismutase (EC-SOD) levels were not modulated by either treatment, for olmesartan there was a positive correlation between changes in FMD and those in EC-SOD levels.
In conclusion, olmesartan improved endothelial function in hypertensive patients independent of its BP-lowering effect, which was due, at least in part, to its antioxidative property. Therefore, olmesartan might provide a greater long term benefit for hypertensive patients with impaired endothelial function than 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
2009 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 07 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 15 Day
Last modified on
2011 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003205

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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