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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001688
Receipt No. R000002036
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
Date of disclosure of the study information 2009/02/05
Last modified on 2013/02/06

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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
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
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
Registered date File name


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