Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension (Benibest)

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

Study type: Interventional

Funder types: Industry

Identifiers

NCT00890591

SPB-OM-0106

Details and patient eligibility

About

In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.

Enrollment: 144 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage 1 and 2 hypertension without treatment for at least 2 weeks
• Women with no risk of becoming pregnant

Exclusion criteria

• Study participation could result in risk to health of subject
• Cardiovascular disease
• Secondary hypertension or stage 3 hypertension
• Myocardial infarction within the last 6 months
• Congestive heart failure
• Pulmonary edema
• Valvular alterations or rheumatic cardiopathy
• Clinically relevant conduction disorders significant arrhythmias
• Alcohol or illicit drug use
• Medication abuse
• Pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 1 patient group

Treatment

Experimental group

Treatment:

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary