UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006691 |
|---|---|
| Receipt number | R000007908 |
| Scientific Title | Effect of Atorvastatin and Amlodipine on pressure-diuresis curve |
| Date of disclosure of the study information | 2011/11/08 |
| Last modified on | 2014/05/19 08:54:56 |
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Basic information
Public title
Effect of Atorvastatin and Amlodipine on pressure-diuresis curve
Acronym
Effect of Atorvastatin and Amlodipine on pressure-diuresis curve
Scientific Title
Effect of Atorvastatin and Amlodipine on pressure-diuresis curve
Scientific Title:Acronym
Effect of Atorvastatin and Amlodipine on pressure-diuresis curve
Region
| Japan |
Condition
Condition
Patients with salt sensitive hypertension and LDL hyperlipemia
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the atorvastatin which carried out additional medication to the salt-sensitive-hypertension patient under amlodipine medication makes increase inclination of a pressure-diuresis curve.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pressure-diuresis curve
Key secondary outcomes
changes in value of the following data from baseline to the end of examination(Blood Pressure, Urine volume, urinary sodium concentration, urinary potasium concentration, urinary neutrophil gelatinase associated lipocalin2 (NGAL) consentration, urinary 8OH-dG concentration, total cholesterol, low density lipoprotein, triglyceride, high density lipoprotein, high sensitive C-reactive protein, serum Urea, serum creatinine, serum Na,K,Cl, plasma renin activity, plasma aldosterone concentration )
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 | Food |
Interventions/Control_1
A salt restricted diet for three days is given to the patient under 5 mg of amlodipine administration. Then 10mg of atorvastatin added, a salt restricted diet for three days is given to the patient.
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) hypertension (systoric BP>140mmHg or diastoric BP>90mmHg) 2) hyper LDL-C (>120mg/dl) without statin treatment 3) serum Cr < 3.0mg/dl 4) over 20 years old 5) obtain written informed consent.
Key exclusion criteria
1) a patient who is treated with diuretics. 2) a patient who is treated with statins. 3) poor controlled hypertension (systoric BP>180mmHg or diastoric BP>110mmHg) 4) patient with heavy cardiovascular disease 5) hepatitis (ALT over three folds increase by normal limits) 6) pregnancy, child bearing potential pre- or nursing 7) uncontrolled arrhythmia 8) inadequate due to other reason by attending physician's judgments 9) history of hypersensitivity to atorvastatin
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato KASAHARA |
Organization
Kyoto University Hospital
Division name
Institute for Advancement of Clinical and Translational Science (iACT)
Zip code
Address
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4724
kasa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato KASAHARA |
Organization
Kyoto University Hospital
Division name
Institute for Advancement of Clinical and Translational Science (iACT)
Zip code
Address
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4724
Homepage URL
kasa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
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 | 11 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 08 | Day |
Last modified on
| 2014 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007908
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