UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013519 |
|---|---|
| Receipt number | 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 10:39:45 |
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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
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
hoshide@jichi.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015797
