UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006974 |
|---|---|
| Receipt number | R000008177 |
| Scientific Title | Research of Aldosterone Breakthrough by Aliskiren |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2011/12/28 13:29:55 |
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Basic information
Public title
Research of Aldosterone Breakthrough by Aliskiren
Acronym
Research of Aldosterone Breakthrough by Aliskiren
Scientific Title
Research of Aldosterone Breakthrough by Aliskiren
Scientific Title:Acronym
Research of Aldosterone Breakthrough by Aliskiren
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the incidence of aldosterone breakthrough,antihypertensive effect, and organ protection by aliskiren treatment in hypertensive patients.
In addition, This study aimed to compare the incidence of aldosterone breakthrough, antihypertensive effect, and organ protective effects of control drug valsartan and aliskiren.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma aldosterone concentration, Plasma renin activity
Blood pressure(On visit/Home monitoring)
Improvement of hypertensive target organ damage measured as urinary albumin excretion ratio
Key secondary outcomes
Ambulatory blood pressure monitoring
Chages in left ventricular hypertrophy(electrocardiogram and echocardiography)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
aliskiren
Interventions/Control_2
valsartan
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Hypertensive patients who did not reach the recommendation of Hypertension Guidelines issued by Japanese Association of Hypertension 2009
2)Without taking RAAS inhibitor
3)Both inpatient and out patient
4)Subjects who gave written informed consent
Key exclusion criteria
1)Pregnancy or Breastfeeding
2)Malignant hypertension, secondary hypertension
3)Patients with severe cardiovascular deseases or history(history of acute coronary syndrome, stroke within 6 month)
4)Patients with severe liver damage
5)Hypersensitivity of aliskiren or valsartan
6)Patients who receive Hormone replacement therapy
7)Anyconditions not suitable for the participation in this trial judged by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Internal Medicine
Zip code
Address
13-1 Takaramachi, Kanazawa city, Ishikawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanazawa University Hospital
Division name
Internal Medicine
Zip code
Address
13-1 Takaramachi, Kanazawa city, Ishikawa, Japan
TEL
Homepage URL
Sponsor or person
Institute
Control of organ function, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2011 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008177
