Olmesartan as an add-on to Amlodipine in Hypertension

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: amlodipine; Drug: hydrochlorothiazide; Drug: olmesartan medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00220233

CS8663-A-E303

Details and patient eligibility

About

This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
• Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg

Exclusion criteria

• Secondary hypertension
• Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)