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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010163
Receipt No. 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

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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
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
TEL 0285-58-7344
Homepage URL
Email kkario@jichi.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical
University School of Medicine.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011886

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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