UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002631 |
|---|---|
| Receipt number | 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 13:30:19 |
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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
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
ayaori@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003205
