UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The combined therapy with Olmesartan and Azelnidipin in the hypertensive patients with sleep apnea syndrome (SAS)
Title of the study (Brief title)	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	Yoshiyu Takeda
Organization	Kanazawa University Hospital
Division name	Department of Endocrinology and Metabolism
Address	13-1 takara-machi, Kanazawa, Japan
TEL	076-265-2252
Email

Public contact
Name of contact person	Yoshiyu Takeda
Organization	Kanazawa University Hospital
Division name	Department of Endocrinology and Metabolism
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000008333