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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013519
Receipt No. R000015797
Scientific Title Effects of morning or bedtime dosing of the valsartan/amlodipine on nocturnal blood pressure and target organ protection in patients with hypertension
Date of disclosure of the study information 2014/03/26
Last modified on 2015/10/26

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Basic information
Public title Effects of morning or bedtime dosing of the valsartan/amlodipine on nocturnal blood pressure and target organ protection in patients with hypertension
Acronym ChronotheraPy for ambulatory cEnTral pressure (CPET)
Scientific Title Effects of morning or bedtime dosing of the valsartan/amlodipine on nocturnal blood pressure and target organ protection in patients with hypertension
Scientific Title:Acronym ChronotheraPy for ambulatory cEnTral pressure (CPET)
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of morning or bedtime dosing of the angiotensin receptor blocker (ARB; valsartan)/ calcium channel blocker (CCB; amlodipine) combination on nocturnal blood pressure and target organ damage in patients with hypertension.
We test the hypothesis whether morning dosing of ARB/CCB combination is not inferior to bedtime dosing for reducing sleep systolic blood pressures (SBP) assessed by ambulatory blood pressure monitoring (ABPM) in hypertensive Japanese patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in sleep blood pressure evaluated by ABPM before and after ARB/CCB combination dosing.
Key secondary outcomes 1. Change in clinic BP or pulse rate before and after ARB/CCB combination dosing; target BP achieving level.
2. Change in daytime (waking hour) BP, morning BP, morning surge and BP variability (SD) assessed by ABPM.
3. Change in ambulatory central BP, augmentation index, cardiac output, total peripheral vascular resistance, pulse wave velocity before and after ARB/CCB combination dosing.
4. Change in home BP, pulse rate, diurnal variation of BP, differences in morning and evening blood pressure before and after ARB/CCB combination dosing.
5. Change in the effects on cardiac function (NT -pro BNP, high-sensitive [hs] cardiac troponin T [hs-cTnT]) before and after ARB/CCB combination dosing.
6. Change in the effects on anti-inflammatory effects before and after ARB/CCB combination dosing.
7. Change in the effects on renal function (urinary albumin excretion rate) before and after ARB/CCB combination dosing.
8. To evaluate the safety of test drug (e.g., adverse events) other than primary outcome.

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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm A receives valsartan/amlodipine combination once daily in the morning for 8 weeks, after that switches to before bedtime dose for 8 weeks.
Interventions/Control_2 Arm B receives valsartan/amlodipine combination once daily before bedtime for 8 weeks, after that switches to morning dose for 8 weeks.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Hypertensive patients with an average clinic systolic blood pressure (SBP) of 140 mmHg or higher or diastolic blood pressure (DBP) of 90 mmHg or higher on at least medicated by CCB or ARB standard or maximum dose for 4 weeks or more.
Key exclusion criteria 1) History of hypersensitivity to test drug or dihydropyridine compounds.
2) Patients being treated concomitantly with hypertensive drugs other than ARB or CCB
3) Secondary hypertension or malignant hypertension.
4) Severe heart failure (New York Heart Association (NYHA) functional class III or more).
5) Severe kidney disease with serum creatinine level 3.0mg/dL or higher, or on dialysis
6) Severe liver and biliary system disorders.
7) History of cardiovascular (myocardial infarction) or cerebrovascular (cerebral infarction) event
8) Patients with endocrine disease.
9) Patients with malignant neoplasms
10) Pregnant or women of child bearing potential
11) Patients who is not given informed consent by themselves
12) Patients decided inappropriate subjects for this study by physicians
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University
Division name Division of Cardiovascular Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
TEL 0285-58-7344
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hoshide
Organization Jichi Medical University
Division name Division of Cardiovascular Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
TEL 0285-58-7344
Homepage URL
Email hoshide@jichi.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine
Jichi Medical University
Institute
Department

Funding Source
Organization Novartis Pharma K.K.
Organization
Division
Category of Funding Organization Profit organization
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 自治医科大学付属病院(栃木県)
福島県立南会津病院(福島県)
東吾妻町国民健康保険診療所(群馬県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 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
2012 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 14 Day
Last follow-up date
2015 Year 08 Month 14 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 26 Day
Last modified on
2015 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015797

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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