UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009266 |
|---|---|
| Receipt number | R000010869 |
| Scientific Title | Randomized controlled trail on efficacy and safety of ARB and losartan potassium/Hydrochlorothiazide in hypertension patients |
| Date of disclosure of the study information | 2012/11/10 |
| Last modified on | 2012/11/10 04:44:03 |
* 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
Randomized controlled trail on efficacy and safety of ARB and losartan potassium/Hydrochlorothiazide in hypertension patients
Acronym
ABC study
Scientific Title
Randomized controlled trail on efficacy and safety of ARB and losartan potassium/Hydrochlorothiazide in hypertension patients
Scientific Title:Acronym
ABC study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of Losartan /HCTZ and ARBs/Calcium antagonist on blood pressure and lipid metabolism in hypertension patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change of serum-lipids, apolipoproteins and inflammation marker in all trial period within 2 groups.
Serum-lipids: Total cholesterol, Triglyceride, HDL-C, LDL-C
Apolipoprotein: apo-AI, apo-B, apo-E
Inflammation marker: hs-CRP
Key secondary outcomes
Change of Blood pressure and eGFR in all trial period within 2 groups.
Change of FBS, HbA1c, S-Cr, S-Na, S-K, and Uric acid.
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Losartan/HCTZ
Interventions/Control_2
ARB/Calsium antagonist
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for study patients:
1) Hypertension Patient who has previously been treated with ARB normal dose*1 monotherapies at least for 1 months and whose blood pressure has not been adequately controlled*2
*1 ARB normal dose: Losartan 50 mg,
Candesartan 8 mg,
Valsartan 80 mg,
Telmisartan 40 mg,
Olmesartan 20 mg.
*2 BP Target
SBP < 140 mmHg and DBP < 90 mmHg
(DM or CKD : SBP < 130 mmHg and DBP < 80 mmHg)
2) Patient of between 20 and 74 years of age
3) Both genders is included
4) In and out patients
5) Patient who understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start.
Key exclusion criteria
Exclusion criteria
1) Patients with IDDM
2) Patients with nephropathy (urinary albumin-to-creatinine ratio > 300mg/gCr)
3) Patients with poor controlled diabetes mellitus (HbA1c > 10.0%)
4) Patients during insulin treatment
5) Patients with poor controlled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
6) Patients with malignant hypertension
7) Patients with a critical liver damage (ALT or AST is over 3 times of normal)
8) Patients with attack of gout in past
9) Patient has had any severe cardiovascular events with hospitalization within the 6 months prior to informed consent.
10) Patient is pregnant or breast feeding, or is a female expecting to conceive within the projected duration of the study.
11) Patients with the secondary hypertension
12) Patients with non-diabetic nephropathy such as chronic glomerulonephritis, polycystic nephropathy and reniculus etc.
13) Patients with heart failure (above NYHA grade III)
14) Patient has poor controlled arrhythmia
15) Patients has treated with diuretic
16) Patients has allergia of test drugs
17) Patients who are considered to be not eligible to the study by the investigator due to medical reasons.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Nakamura |
Organization
Mitsukoshi Health and Welfare Foundation
Division name
Standing director
Zip code
Address
1-24-1, Nishi-shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hosoai |
Organization
Executive office of ABC study
Division name
Representation
Zip code
Address
TEL
0333485791
Homepage URL
hiroshi@hosoai.com
Sponsor or person
Institute
Executive office of ABC study
Institute
Department
Personal name
Funding Source
Organization
Japan Vascular Disease Research foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 11 | Month | 10 | 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
Completed
Date of protocol fixation
| 2008 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 06 | Day |
Last modified on
| 2012 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010869
