UMIN-CTR Clinical Trial

Basic information
Public title	Combination of Antihypertensive therapy in the elderly, Multicenter Investigation <CAMUI> Multi-center randomized controlled study on efficacy of ARB/Diuretic mixture versus ARB/Ca channel blocker combination therapy to blood pressure or cognitive function in the elderly patients who have insufficient controlled hypertension in ARB monotherapy
Acronym	Combination of Antihypertensive therapy in the elderly, Multicenter Investigation <CAMUI>
Scientific Title	Combination of Antihypertensive therapy in the elderly, Multicenter Investigation <CAMUI> Multi-center randomized controlled study on efficacy of ARB/Diuretic mixture versus ARB/Ca channel blocker combination therapy to blood pressure or cognitive function in the elderly patients who have insufficient controlled hypertension in ARB monotherapy
Scientific Title:Acronym	Combination of Antihypertensive therapy in the elderly, Multicenter Investigation <CAMUI>
Region	Japan

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

Objectives
Narrative objectives1	To compare the efficacy of PREMINENT (Losartan 50 mg/HCTZ 12.5 mg) and ARB/Ca channel blocker combination therapy to blood pressure in the elderly patients with essential hypertension who were failed monotherapy with ARB. We examine non-inferiority of PREMINENT to ARB/Ca channel blocker combination therapy for reduction of blood pressure. Furthermore, we also verify the effect to renal function or cognitive function between both groups.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Systolic/Diastolic blood pressure change during three month treatment.
Key secondary outcomes	MMSE score change. The rate of achieving the target blood pressure. The change of laboratory test results, including as HbA1c, HOMA-R, FBS, UP, microalbuminuria, K, and uric acid. The rate of continued treatment and the compliance of the treatment. Rates of adverse experiences

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	PREMINENT group To 3 month: PREMINENT (combination drug: Losartan 50 mg/HCTZ 12.5 mg) From 4 to 6 month: ARB addded if needed. From 7 to 12 month: alpha blocker, beta blocker, and/or centrally acting sympatholytic drug added if neeeded
Interventions/Control_2	ARB and amlodipine group To 3 month: ARB (recommended dose)and amlodipine 5mg From 4 to 6 month: ARB increased if needed. From 7 to 12 month: alpha blocker, beta blocker, and/or centrally acting sympatholytic drug added if neeeded
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with essential hypertension, who have been previously treated with ARB monotherapy (Losartan 50 mg, candesartan 8 mg, valsartan 80 mg, telmisartan 40 mg, or olmesartan 20 mg) for more than a month and whose blood pressure has not been adequately controlled with the treatment (SBP >=140 mmHg and/or DBP >=90mmHg:In the case of diabetes or renal disease, SBP >=130 mmHg and/or DBP >=80mmHg). 2) 65 years age or more 3) Both gender is included 4) Outpatients 5) Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start.
Key exclusion criteria	1) Patients with the secondary hypertension 2) Patients with heart failure: >= NYHA grade III 3) Patient with a history of severe renal disease: serum creatinine>= 2.0 mg/dl 4) Patients with critical liver damage: ALT or ASTis 3 times of normal upper level or more 5) Patients with a history of hypersensitivity to PREMINENT 6) Patients with a history of hypersensitivity to components of thiazide or similar compounds 7) 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 Naoyuki Hasebe
Organization	Asahikawa Medical College
Division name	Cardiovascular Division, Department of Internal Medicine
Zip code
Address	Midorigaoka, E2-1-1-1 Asahikawa, Hokkaido 078-8510, Japan
TEL	0166-68-2442
Email

Public contact
Name of contact person	1st name Middle name Last name Nobuyuki Sato
Organization	Asahikawa Medical College
Division name	Cardiovascular Division, Department of Internal Medicine
Zip code
Address	Midorigaoka, E2-1-1-1 Asahikawa, Hokkaido 078-8510, Japan
TEL	0166-68-2442
Homepage URL
Email

Sponsor
Institute	Elderly Hypertension Conference
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
Address
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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	2009 Year 02 Month 05 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 07 Month 31 Day
Date of IRB
Anticipated trial start date	2008 Year 11 Month 01 Day
Last follow-up date	2011 Year 10 Month 01 Day
Date of closure to data entry	2011 Year 12 Month 01 Day
Date trial data considered complete	2012 Year 03 Month 01 Day
Date analysis concluded	2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2009 Year 02 Month 05 Day
Last modified on	2013 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002036

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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