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UMIN-CTR Clinical Trial |
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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 |
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 |
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Acronym | Combination of Antihypertensive therapy in the elderly, Multicenter Investigation
<CAMUI> |
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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 |
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Scientific Title:Acronym | Combination of Antihypertensive therapy in the elderly, Multicenter Investigation
<CAMUI> |
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Region |
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Condition | ||
Condition | Hypertension
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Classification by specialty |
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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.
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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 |
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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 |
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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 |
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Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
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Name of contact person |
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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 | |
Institute | Elderly Hypertension Conference |
Institute | |
Department |
Funding Source | |
Organization | The Waksman foundation of JAPAN INC |
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Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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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 |