UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007171 |
|---|---|
| Receipt number | R000008333 |
| Scientific Title | The combined therapy with Olmesartan and Azelnidipin in the hypertensive patients with sleep apnea syndrome (SAS) |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2018/02/11 00:51:58 |
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Basic information
Public title
The combined therapy with Olmesartan and Azelnidipin in the hypertensive patients with sleep apnea syndrome (SAS)
Acronym
The combined therapy with Olmesartan and Azelnidipin in the hypertensive patients with sleep apnea syndrome (SAS)
Scientific Title
The combined therapy with Olmesartan and Azelnidipin in the hypertensive patients with sleep apnea syndrome (SAS)
Scientific Title:Acronym
The combined therapy with Olmesartan and Azelnidipin in the hypertensive patients with sleep apnea syndrome (SAS)
Region
| Japan |
Condition
Condition
Sleep Apnea Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the combined therapy with Olmesartan and Azelnidipine in the hypertensive patients with SAS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure(Clinic BP,Home BP)
Key secondary outcomes
PSG, AHI, noradrenalin, cortisol, Plasma aldosterone concentration, Plasma renin activity, ACTH, BNP,blood sugar level, renal function(the very-small-quantity albumin in urine, albuminuria, eGFR), Salt intake,HOMA-R, PAI-1, adiponectin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Add Azelnidipine (8-16mg/day) to patients treated with olmesartan(20mg/day)
Interventions/Control_2
Add Amlodipine(2.5-5mg/day) to patients treated with olmesartan(20mg/day)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The hypertensive patients with SAS.
2) Hypertensive patients who did not reach target BP(defined by JSH2009) in spite of monotherapy of Olmesaltan.
3) Patients wiht AHI of15-20 or patients for whom CPAP introduction is improper at 40 or more AHI
Key exclusion criteria
1) The patient who is taking azelnidipine or amlodipine
2) The patient who has critical liver disease. (AST or ALT is 100 or more IU/L)
3) The patient who has a critical renal disease (the patient under dialysis enforcement is included).
(more than BUN 25mg/dL or more than serum creatinine 2.0mg/dL)
4) Pregnant or lactating women
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 takara-machi, Kanazawa, Japan
TEL
076-265-2252
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 takara-machi, Kanazawa, Japan
TEL
076-265-2252
Homepage URL
Sponsor or person
Institute
Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2012 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 30 | Day |
Last modified on
| 2018 | 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=R000008333
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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