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

UMIN ID: UMIN000001688

Registered date:05/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2008/11/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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
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

Outcome(s)

• Primary Outcome: Systolic/Diastolic blood pressure change during three month treatment.
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Elderly Hypertension Conference
• Source(s) of Monetary Support: The Waksman foundation of JAPAN INC