UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004909 |
|---|---|
| Receipt number | R000005847 |
| Scientific Title | The comparison of the effect of calcium channel blockers on blood pressure lowering and presevation of renal function in refractory hypertensive patients |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2013/07/26 11:04:00 |
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Basic information
Public title
The comparison of the effect of calcium channel blockers on blood pressure lowering and presevation of renal function in refractory hypertensive patients
Acronym
The comparison of the effect of CCBs on BP and renal function in refractory hypertensive patients
Scientific Title
The comparison of the effect of calcium channel blockers on blood pressure lowering and presevation of renal function in refractory hypertensive patients
Scientific Title:Acronym
The comparison of the effect of CCBs on BP and renal function in refractory hypertensive patients
Region
| Japan |
Condition
Condition
refractory hypertension
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference of the effect of two dihydropyridine calcium channel blockers, amlodipine and nifedipine CR on blood pressure lowering, preservation of renal function and maker for endothelial cell function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure lowering between 2 remedies (delta SBP and delta DBP after 3, 6, and 12 month)
Key secondary outcomes
1)achievement rate of target blood pressure
2)change in renal dysfunction
3)change in hs-CRP
4)change in endocrine system
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nifedipine CR 40mg (6 months), then Amlodipine 5mg (6 months)
Interventions/Control_2
Amlodipine 5mg (6 months), then Nifedipine CR 40mg (6 months)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
refractory hypertensive patients with
1. office blood pressure>=140/90 mmHg or more
2. DM, CKD, MI patients: BP>=130/80 mmHg or more (*patients with proteinuria BP>=1g/gCr: 125/75 mmHg)
3. CVA patients: BP>=140/90 mmHg or more
Key exclusion criteria
1. taking Nifedipine or Amlodipine
2. history of hypersensitivity to Amlodipine and/or Nifedipine
3. secondary hypertension
4. pregnant, becoming pregnant
5. cardiogenic shock
6. planning dialysis within 1 year
7. regarded as inadequate for enrollment by investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Yasuda |
Organization
St. Marianna University School of Medicine
Division name
Nephrology and Hypertension
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511 Japan
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yasuda |
Organization
St. Marianna University School of Medicine
Division name
Nephrology and Hypertension
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511 Japan
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
聖マリアンナ医科大学(神奈川県)/St. Marianna University School of Medicine(Kanagawa Pref.)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 14 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 22 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 20 | Day |
Last modified on
| 2013 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005847
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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