UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010163 |
|---|---|
| Receipt number | R000011886 |
| Scientific Title | Effects of Aliskiren and Amlodipine Combination Therapy or High-dose Amlodipine Monotherapy on Ambulatory Blood Pressure in Hypertensive Patients |
| Date of disclosure of the study information | 2013/03/06 |
| Last modified on | 2013/10/10 09:28:26 |
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Basic information
Public title
Effects of Aliskiren and Amlodipine Combination Therapy or High-dose Amlodipine Monotherapy on Ambulatory Blood Pressure in Hypertensive Patients
Acronym
Aliskiren Combination with Amlodipine on Target Organ Damage: ACAT study
Scientific Title
Effects of Aliskiren and Amlodipine Combination Therapy or High-dose Amlodipine Monotherapy on Ambulatory Blood Pressure in Hypertensive Patients
Scientific Title:Acronym
Aliskiren Combination with Amlodipine on Target Organ Damage: ACAT study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the additional effects of 150-300 mg aliskiren or 5mg amlodipine on 24-hour ambulatory blood pressure and vascular function in uncontrolled hypertensive patients with 5mg amlodipine monotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ambulatory blood pressure monitoring (ABPM)
Pulse wave velocity (PWV)
Key secondary outcomes
Clinic BP, home BP, endothelial function (flow-mediated dilatation), plasma renin activity, plasma aldosterone, microalbuminuria, urinary sodium excretion, NT pro-BNP, high-sensitive CRP, high-sensitive troponin-T, cystatin C.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After 5mg amlodipine monotherapy for 4 weeks run-in period, 150mg aliskiren is added for first 8 weeks, and dose of aliskiren is doubled to 300mg for next 8 weeks.
Interventions/Control_2
After 5mg amlodipine monotherapy for 4 weeks run-in period, dose of amlodipine is doubled to 10mg throughout 16 weeks treatment 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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with clinic or home BP > 140mmHg in systolic and/or > 90mmHg in diastolic (systolic BP > 130mmHg and/or diastolic BP > 85mmHg in case of diabetes), although receiving 5mg amlodipine monotherapy for 4 weeks period or more.
Key exclusion criteria
1) Secondary hypertension
2) Moderate to severe symptom of heart failure (New York Heart Association >class III), fatal arrhythmia
3) A history of stroke, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft within the past 6 months
4) Severe renal dysfunction (eGFR <30ml/min/1.73m2, or serum creatinine >2.0mg/dl)
5) Severe hepatic disease
6) Uncontrolled diabetes (HbA1c >12%)
7) Pregnant women
8) A history of allergy/hypersensitivity to dihydropyridine calcium channel blockers
9) Patients receiving other antihypertensive drugs than amlodipine
10) Patients receiving P-glycoprotein inhibitor
11) Severe dementia
12) Not eligible for this study based on the decision's of a physician
Target sample size
110
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
TEL
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
TEL
0285-58-7344
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical
University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical
University School of Medicine.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukushima Prefectural Miyashita Hospital
Yanai Municipal Heigun Clinic
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
福島県立宮下病院 (福島県), 柳井市立平郡診療所 (山口県).
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 06 | 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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 05 | Day |
Last modified on
| 2013 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011886
