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

This study has been completed.
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Information provided by:
Daiichi Sankyo, Inc. Identifier:
First received: March 3, 2009
Last updated: September 28, 2010
Last verified: September 2010
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.

Condition Intervention Phase
Essential Hypertension Drug: olmesartan medoxomil Drug: losartan potassium Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Change of trough seated diastolic blood pressure from baseline to 8 weeks [ Time Frame: Baseline to 8 weeks ]

Enrollment: 287
Study Start Date: August 2004
Study Completion Date: April 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
olmesartan medoxomil
Drug: olmesartan medoxomil
oral tablets, once daily for 8 weeks
Active Comparator: 2
losartan potassium
Drug: losartan potassium
capsules, once daily for 8 weeks


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00856271

Beijing, China
Chongqing, China
Guang Zhou, China
Nanjing, China
Shanghai, China
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Study Director: Vice President Sankyo Shanghai Pharmaceuticals
  More Information

Responsible Party: Naotaka Ikegami, Vice President, Shanghai Sankyo Pharmaceuticals, Co., Ltd. Identifier: NCT00856271     History of Changes
Other Study ID Numbers: SS-866/01
Study First Received: March 3, 2009
Last Updated: September 28, 2010

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Olmesartan Medoxomil
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017