Vascular Improvement With Olmesartan Medoxomil Study (VIOS)

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure; Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772499

866-432

Details and patient eligibility

About

The purpose of this study is to compare in patients with primary hypertension, the non-blood pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol on changes in the vascular structure and function.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• 18-75 years of age
• Mean seated diastolic BP 90-109 or mean seated systolic BP of 140-179

Exclusion criteria

• Secondary hypertension
• Renal disease
• Diabetes mellitus
• Serum creatinine >3.0 mg/dL
• Hemoglobin <10 mg/dL (males) or <9mg/dL (females)
• WBC count <2000 cells/mL
• Platelet count <100,000 cells/mL
• Either ALT & AST >2.5 x upper limit of normal
• BMI >35 kg/m2
• TIA or cerebrovascular attack within 3 months of study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Experimental group

Description:

olmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure

Treatment:

Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure

2

Active Comparator group

Description:

Atenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure

Treatment:

Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure