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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010600
Receipt No. R000012391
Scientific Title The effect of bedtime dosing of antihypertensive drug with both alfa and beta sympatholytic action in high-risk obstructive sleep apnea hypertensive patients
Date of disclosure of the study information 2013/04/26
Last modified on 2013/04/26

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Basic information
Public title The effect of bedtime dosing of antihypertensive drug with both alfa and beta sympatholytic action in high-risk obstructive sleep apnea hypertensive patients
Acronym The VSSPS (Vasodilation vs Sympatholytic antihypertensives on Sleep blood Pressure in hypertensive patients with Sleep apnea syndrome) study.
Scientific Title The effect of bedtime dosing of antihypertensive drug with both alfa and beta sympatholytic action in high-risk obstructive sleep apnea hypertensive patients
Scientific Title:Acronym The VSSPS (Vasodilation vs Sympatholytic antihypertensives on Sleep blood Pressure in hypertensive patients with Sleep apnea syndrome) study.
Region
Japan

Condition
Condition hypertension with obstructive sleep apnea syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The patients with obstructive sleep apnea syndrome (OSAS) occurs micro-arousal induced apnea during sleep, which lead to sympathetic nervous activation. The blood pressure (BP) surge during sleep in the patients with OSAS might be caused by sympathetic nervous activation. The aim of this study is to compare the effect of carvedilol that have the inhibition of both alfa and beta sympatholytic action with nifedipine on BP surge during sleep in the patients with OSAS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in the inhibition of BP surge during sleep between two groups.
Key secondary outcomes Maximum, minimum and average BP during sleep, morning BP, AHI

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carvedilol 10-20mg one time dose, followed by Nifedipine 20-40mg one time dose after the 2weeks washout period.
Interventions/Control_2 Nifedipine 20-40mg one time dose, followed by Carvedilol 10-20mg one time dose after the 2weeks washout period.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hypertensive subjects with OSAS (AHI>15/hr) 1) who were diagnosed previously by the polysomnography, 2) who were unwilling to receive continuous positive airway pressure (CPAP), and whose sleep BP (measured by ABPM) >120/70 mmHg, were recruited.
Key exclusion criteria Exclusion criteria as follows
1) The patients treated with anti-sympathetic nervous activation agents
2) The patients with bedtime dosing of antihypertensive drug
3) The patients with congestive heart failure (more than NYHA II)
4) The patients with malignancy
5) The patients with renal failure (serum creatinine >2.0 mg/dL) or performing hemodialysis or severe liver dysfunction
6) The patients with contraindication of these drugs
7) The patients with past history of serious side effects
8) The patients who is not given informed consent by themselves
9) The patients decided inappropriate subjects for this study by physicians
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL +81-285-58-7538
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 鷲谷病院 Washiya hospital

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 26 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 Completed
Date of protocol fixation
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 26 Day
Last modified on
2013 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012391

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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