UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005817 |
|---|---|
| Receipt number | R000006830 |
| Scientific Title | The Effect of Using Candesarsan and Amlodipine for Hypertensive Patients with Dyslipidemia in Japan |
| Date of disclosure of the study information | 2011/06/22 |
| Last modified on | 2011/06/21 13:23:27 |
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Basic information
Public title
The Effect of Using Candesarsan and Amlodipine for Hypertensive Patients with
Dyslipidemia in Japan
Acronym
EARTH-trial
Scientific Title
The Effect of Using Candesarsan and Amlodipine for Hypertensive Patients with
Dyslipidemia in Japan
Scientific Title:Acronym
EARTH-trial
Region
| Japan |
Condition
Condition
Hypertension, Dyslipidemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate pressure-lowering effect, insulin resistance and the effect of lipid metabolism using candesartan or amlodipine in hypertensive patients with dyslipidemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The blood pressure-lowering effect was not significant difference among candesartan and amlodipine groups. Moreover, candesartan group was not worsening insulin resistance and the effect of lipid metabolism in hypertensive patients with dyslipidemia.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Hypertensive patients
Systolic blood pressure>140 mmHg
or
Diastolic blood pressre.90 mmHg
or
Already taking antihypertensive drugs
2. High levels of LDL cholesterol patients
LDL-C>140 mg/dl
or
LDL-C>100 mg/dl and need to take statints by attending physician
or
Already taking statins
Key exclusion criteria
1.Malignancy
2.Contraindication to take candesartan, amlodipine and pitabastatin.
3.Familial hypercholesterolemia
4.Acute coronary syndrome
5.Already enrollment other clinical trials.
6.Mismatched patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Funada |
Organization
The Cardiovascular Institute
Division name
Division of Cardiology
Zip code
Address
3-2-19, Nishiazabu Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Cardiovascular Institute
Division name
Division of Cardiology
Zip code
Address
TEL
03-3408-2151
Homepage URL
Sponsor or person
Institute
The Cardiovascular Institute
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
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 | 06 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2011 | Year | 06 | Month | 21 | Day |
Last modified on
| 2011 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006830
