Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: losartan potassium; Drug: olmesartan medoxomil

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00856271

SS-866/01

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.

Enrollment: 287 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and <110 mmHg, mean seated systolic blood pressure < 180 mmHg)
• able to give written informed consent

Exclusion criteria

• known or suspected secondary hypertension
• history of chronic hepatic diseases
• obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
• cardiac arrhythmia
• unstable angina pectoris
• congestive heart insufficiency (New York Heart Association classification III-IV)
• bilateral renal artery stenosis
• isolated renal artery stenosis
• post renal transplantation
• history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment
• retina bleeding/effusion
• insulin dependent diabetes mellitus
• uncontrolled non-insulin dependent diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

287 participants in 2 patient groups

1

Experimental group

Description:

olmesartan medoxomil

Treatment:

Drug: olmesartan medoxomil

2

Active Comparator group

Description:

losartan potassium

Treatment:

Drug: losartan potassium