Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: olmesartan medoxomil (Drug); losartan potassium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Daiichi Sankyo Inc. Official(s) and/or principal investigator(s): Vice President, Study Director, Affiliation: Sankyo Shanghai Pharmaceuticals
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change of trough seated diastolic blood pressure from baseline to 8 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Beijing, China
Chongqing, China
Guang Zhou, China
Nanjing, China
Shanghai, China
Additional Information
Starting date: August 2004
Last updated: September 28, 2010
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