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 |
Effects of morning or bedtime dosing of the valsartan/amlodipine on nocturnal blood pressure and target organ protection in patients with hypertension
ChronotheraPy for ambulatory cEnTral pressure (CPET)
Effects of morning or bedtime dosing of the valsartan/amlodipine on nocturnal blood pressure and target organ protection in patients with hypertension
ChronotheraPy for ambulatory cEnTral pressure (CPET)
Japan |
Hypertension
Cardiology |
Others
NO
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.
Safety,Efficacy
Change in sleep blood pressure evaluated by ABPM before and after ARB/CCB combination dosing.
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.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
NO
NO
Central registration
2
Treatment
Medicine |
Arm A receives valsartan/amlodipine combination once daily in the morning for 8 weeks, after that switches to before bedtime dose for 8 weeks.
Arm B receives valsartan/amlodipine combination once daily before bedtime for 8 weeks, after that switches to morning dose for 8 weeks.
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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
26
1st name | |
Middle name | |
Last name | Kazuomi Kario |
Jichi Medical University
Division of Cardiovascular Medicine
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
0285-58-7344
kkario@jichi.ac.jp
1st name | |
Middle name | |
Last name | Satoshi Hoshide |
Jichi Medical University
Division of Cardiovascular Medicine
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
0285-58-7344
hoshide@jichi.ac.jp
Division of Cardiovascular Medicine
Jichi Medical University
Novartis Pharma K.K.
Profit organization
NO
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)
2014 | Year | 03 | Month | 26 | Day |
Unpublished
Completed
2012 | Year | 11 | Month | 14 | Day |
2012 | Year | 11 | Month | 14 | Day |
2015 | Year | 08 | Month | 14 | Day |
2015 | Year | 09 | Month | 30 | Day |
2014 | Year | 03 | Month | 26 | Day |
2015 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015797