Effects of Aliskiren and Amlodipine Combination Therapy or High-dose Amlodipine Monotherapy on Ambulatory Blood Pressure in Hypertensive Patients

Not Applicable

• Conditions: Hypertension

• Registration Number: JPRN-UMIN000010163
• Lead Sponsor: Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

1) Secondary hypertension 2) Moderate to severe symptom of heart failure (New York Heart Association >class III), fatal arrhythmia 3) A history of stroke, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft within the past 6 months 4) Severe renal dysfunction (eGFR <30ml/min/1.73m2, or serum creatinine >2.0mg/dl) 5) Severe hepatic disease 6) Uncontrolled diabetes (HbA1c >12%) 7) Pregnant women 8) A history of allergy/hypersensitivity to dihydropyridine calcium channel blockers 9) Patients receiving other antihypertensive drugs than amlodipine 10) Patients receiving P-glycoprotein inhibitor 11) Severe dementia 12) Not eligible for this study based on the decision's of a physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ambulatory blood pressure monitoring (ABPM) Pulse wave velocity (PWV)

Secondary Outcome Measures

Name	Time	Method
Clinic BP, home BP, endothelial function (flow-mediated dilatation), plasma renin activity, plasma aldosterone, microalbuminuria, urinary sodium excretion, NT pro-BNP, high-sensitive CRP, high-sensitive troponin-T, cystatin C.