UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009045 |
|---|---|
| Receipt number | R000010621 |
| Scientific Title | Effect of combination therapy with amlodipine and atorvastatin on blood pressure varaiability, vascular function and renal function in hypertensive patients with chronic kidney disease |
| Date of disclosure of the study information | 2012/10/05 |
| Last modified on | 2015/04/06 11:18:54 |
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Basic information
Public title
Effect of combination therapy with amlodipine and atorvastatin on blood pressure varaiability, vascular function and renal function in hypertensive patients with chronic kidney disease
Acronym
Effect of combination therapy with amlodipine and atorvastatin hypertensive patients with chronic kidney disease
Scientific Title
Effect of combination therapy with amlodipine and atorvastatin on blood pressure varaiability, vascular function and renal function in hypertensive patients with chronic kidney disease
Scientific Title:Acronym
Effect of combination therapy with amlodipine and atorvastatin hypertensive patients with chronic kidney disease
Region
| Japan |
Condition
Condition
Hypertension with chronic kidney disease (CKD stage 1-4)
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate the effect of combination therapy with Calucium chanel inhibitor and statin in hypertensive patients with chronic kidney desease. Especially, the therapeutic significance of lowering LDL- choresterol level less than 100-120mg/dL may be obtained.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, abrominal circumference
Office blood pressure and its vriability
Blood examination, Urine examination
Vascular function (ABI/PWV, CAVI, FMD etc...)
Key secondary outcomes
Body weight, abrominal circumference
Office blood pressure and its vriability
Blood examination, Urine examination
Vascular function (ABI/PWV, CAVI, FMD etc...)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Amlodipine/atorvastatin combination tablets
Interventions/Control_2
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
1) CKD stage 1-4
2) Under the antihypertensive therapy
3) Office sytolic BP >= 130mmHg
Office diastolc BP >= 80mmHg
4) LDL-cholesterol >= 100mg/dl
Key exclusion criteria
1) CKD stage 5 or 5D
2) Patients who have allergy for amlodipine or atorvastatin
3) Patients who are pregnant
4) Patients who are unfit for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi Tamura |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2635
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2635
Homepage URL
Sponsor or person
Institute
Yokohama city university hospital
Institute
Department
Personal name
Funding Source
Organization
Non
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 05 | Day |
Last modified on
| 2015 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010621
