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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

Page last updated: August 23, 2015

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