UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009266
Receipt No. 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

* 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
Last 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
Email

Public contact
1st 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
Email hiroshi@hosoai.com

Sponsor
Institute Executive office of ABC study
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.