UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007101 |
|---|---|
| Receipt number | R000008364 |
| Scientific Title | Antihypertensive Efficacy of the Losartan/Hydrochlorothiazide Combination and its Effect on Plasma B-Type Natriuretic Peptide in Hypertensive Patients Uncontrolled by Angiotensin 2 Type 1 Receptor Antagonist Based Therapy |
| Date of disclosure of the study information | 2012/01/19 |
| Last modified on | 2012/01/24 18:03:34 |
* 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
Antihypertensive Efficacy of the Losartan/Hydrochlorothiazide
Combination and its Effect on Plasma
B-Type Natriuretic Peptide in Hypertensive Patients Uncontrolled by Angiotensin 2 Type 1 Receptor Antagonist Based Therapy
Acronym
Southern Heart Conference Clinical research
Scientific Title
Antihypertensive Efficacy of the Losartan/Hydrochlorothiazide
Combination and its Effect on Plasma
B-Type Natriuretic Peptide in Hypertensive Patients Uncontrolled by Angiotensin 2 Type 1 Receptor Antagonist Based Therapy
Scientific Title:Acronym
Southern Heart Conference Clinical research
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a part of intensive medical treatment based on the guideline for treatment of hypertension, a combination drug of an ARB (losartan 50 mg) and a thiazide diuretic (HCTZ 12.5 mg) is to be administered in patients with uncontrolled hypertension, and its antihypertensive effect, B-Type Natriuretic Peptide and safety are to be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Change and % change in BNP after 12 months of treatment
Key secondary outcomes
Change and % change in blood pressure after 1,2,3,6,9,12,18,24,30 and 36 months of treatment
Change and % change in Uric acid, HbA1c, HDL-C, BNP (excluding values at 12 months), Echocardiography, Electrocardiogram after 3,12,24,30 and 36 months of treatment
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1) Patients with essential hypertension, who have been previously treated with antihypertensive drugs including ARB for more than 3 months, however, the target blood pressure defined by the guideline for treatment of hypertension has not been achieved
2) Patiens aged 20 to 79 years at the time of the first visit
3) Outpatients
4) Patients who have given written informed consent on use of theie data for the study
Key exclusion criteria
1) Patients with secondary hypertension
2) Patients with cardiac insufficiency (more than NYHA grade II)
3) Patients under treatment with thiazide diuretic
4) Pregnant patients including one trying to conceive pregnancy during the planned study period
5) Patients with severe liver dysfunction
6) Patients with renal failure (serum creatinine ≥2.0 mg/dL)
7) Patients with a history of hypersensitivity to ingredients of losartan and hydrochlorothiazide
8) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
9) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuji Inou,Hiroshi Meno |
Organization
Fukuoka Red Cross Hospital
Division name
Department of Cardiology and Internal Medicine
Zip code
Address
3-1-1 Ohkusu, Minami-ku Fukuoka
TEL
092-521-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Meno |
Organization
Southern Heart Conference secretariat
Division name
Southern Heart Conference secretariat
Zip code
Address
TEL
092-521-1211
Homepage URL
Sponsor or person
Institute
Southern Heart Conference
Institute
Department
Personal name
Funding Source
Organization
Japan Heart 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 | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2012 | Year | 01 | Month | 19 | Day |
Last modified on
| 2012 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008364
