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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil

Drug

oral tablets, once daily for 8 weeks

Losartan Potassium

Drug

capsules, once daily for 8 weeks

Primary outcomes

Change of trough seated diastolic blood pressure from baseline to 8 weeks

Time frame: Baseline to 8 weeks

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

Shanghai Sankyo Pharmaceuticals Co., Ltd.

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Multi-center Study to Investigate the Safety and Efficacy of Olmesartan Medoxomil Compared With Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Mar 5, 2009
Registry last updated: Sep 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed