Comparison of Sevikar® and the Combination of Perindopril/Amlodipine on Central Blood Pressure

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of the combination of amlodipine with an angiotensin receptor blocker or an angiotensin converting inhibitor, on central arterial blood pressure in patients with hypertension and additional risk factors. This is a randomised, double-blind, double-dummy, multicenter study. The duration of active treatment 24 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Europe, GmbH; Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Treatments: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil; Perindopril

Criteria

Inclusion Criteria:

• moderate to severe hypertension

• 3 additional risk factors such as age > 55 (male), > 65 female, smoker, type 2 diabetes, obesity, cardiovascular disease, congestive heart failure, chronic kidney disease,

• ability to give informed consent

Exclusion Criteria:

• secondary or malignant hypertension

• contraindication to any of the study drugs

• Creatinine clearance level <40ml/min

• treatment with more than 3 antihypertensive drugs

• Myocardial infarction, percutaneous transluminal coronary angioplasty, cardiac bypass surgery < 6 month prior to start of the study,

• unstable angina pectoris,

• stroke, transient ischemic attack < 3 months prior to start,

• Congestive heart failure NYHA II-IV,

• clinically relevant concomitant diseases,

• alcohol or drug abuse,

• pregnancy or women of childbearing potential without contraceptive precaution,