UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001688 |
|---|---|
| Receipt number | 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 16:10:55 |
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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
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
Sponsor or person
Institute
Elderly Hypertension Conference
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002036
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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