UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007171
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.