Skip to content

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00856271
Enrollment
287
Registered
2009-03-05
Start date
2004-08-31
Completion date
2005-04-30
Last updated
2010-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief summary

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.

Interventions

DRUGolmesartan medoxomil

oral tablets, once daily for 8 weeks

DRUGlosartan potassium

capsules, once daily for 8 weeks

Sponsors

Shanghai Sankyo Pharmaceuticals Co., Ltd.
CollaboratorUNKNOWN
Daiichi Sankyo
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026