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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004909
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005847

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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