UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006691
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kasa@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007908

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.