UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of losartan/hydrochlorothiazide vs high-dose angiotensin II receptor blocker(ARB) for uncontrolled hypertensive patients
Acronym	Kobe Combination therapy of Losartan/hydrochlorothiazide,effect and safty trial(Kobe-CONNECT)
Scientific Title	A comparison of losartan/hydrochlorothiazide vs high-dose angiotensin II receptor blocker(ARB) for uncontrolled hypertensive patients
Scientific Title:Acronym	Kobe Combination therapy of Losartan/hydrochlorothiazide,effect and safty trial(Kobe-CONNECT)
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of lowering blood pressure are to be compared between a fixed-dose combination drug of losartan/hydrochlorothiazide and a therapy of a high dose ARB in hypertensive patients whose blood pressure have not been controlled sufficiently.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Change in blood pressure level measured on an outpatient basis after 12 weeks of treatment
Key secondary outcomes	- Change in blood pressure level measured on an outpatient basis after 24,48 weeks of treatment- Changes in blood pressure level at home after getting up,ABPM,NT-proBNP,hs-CRP,PAI-1,Aldosterone after 12, 24 and 48 weeks of treatment- Change in catroid internal-medical thickness after 48 weeks of treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
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/hydrochlorothiazide group
Interventions/Control_2	High-dose ARB group
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	Inclusion criteria:1) Hypertensive patients, who have been previously treated with monotherapy of an ARB or ARB and Carcium channel blocker for more than 8 weeks, however, whose blood pressure has not been reached the target defined by the JSH2004 criteria.2) Men and women aged more than 20 years 3) Outpatients4) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Key exclusion criteria	Exclusion criteria:1) Patients with uncontrolled hypertension (diastolic blood pressure under 110mmHg) 2) Patients with secondary hypertension 3) Patients with uncontrolled diabetes (HbA1c over 8.0%) and under treatment with insulin 4) Patients who have stroke, AMI and/or other critical vascular complications that required hospitalization within 3 months prior to the intervention 5) Patients with liver dysfunction [GPT(ALT) over three times the normal value]6) Patients with renal failure (serum creatinine over 2.0 mg/dL)7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (over 8.0mg/dL)8) Patients with cardiac insufficiency (NYHA grade III )9) Patients with severe malignant cancer or other unfavorable prognostic factors10) Pregnant or possible pregnant women11) Patients , who have been previously treated with diuretics 12) Patients with a history of hypersensitivity to ingredients of losartan potassium or hydrochlorothiazide13) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics13) Patients with a history of hypersensitivity to ingredients of a calcium channel blocker to be used in the study14) 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 Ken-ichi Middle name Last name Hirata
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-1,Kusunoki-Cho,Chuo-Ku,Kobe,650-0017 Japan
TEL	078-382-5846
Email	hiratak@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Ryuji Middle name Last name Toh
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-1,Kusunoki-Cho,Chuo-Ku,Kobe,650-0017 Japan
TEL	078-382-5846
Homepage URL
Email	rtoh@med.kobe-u.ac.jp

Sponsor
Institute	Kobe hypertensive study group
Institute
Department

Funding Source
Organization	The Waksman Foundation of Japan Inc.
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital Clinical and Translational Research Center
Address	7-5-1,Kusunoki-Cho,Chuo-Ku,Kobe,650-0017 Japan
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.jp

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	2008 Year 09 Month 30 Day

Related information
URL releasing protocol	doi: 10.1038/hr.2012.110.
Publication of results	Published

Result
URL related to results and publications	doi: 10.1038/hr.2012.110.
Number of participants that the trial has enrolled	193
Results	doi: 10.1038/hr.2012.110.
Results date posted	2022 Year 10 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	doi: 10.1038/hr.2012.110.
Participant flow	doi: 10.1038/hr.2012.110.
Adverse events	doi: 10.1038/hr.2012.110.
Outcome measures	doi: 10.1038/hr.2012.110.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 08 Month 25 Day
Date of IRB	2008 Year 08 Month 25 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 09 Month 24 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001688