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Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

This study has been completed.
Daiichi Sankyo Taiwan Ltd.
Information provided by:
Daiichi Sankyo, Inc. Identifier:
First received: March 5, 2009
Last updated: July 22, 2009
Last verified: July 2009
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate 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: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker "Olmesartan Medoxomil" Versus "Losartan" 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:
  • Mean Change of Sitting dBP From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ]

Enrollment: 130
Study Start Date: May 2002
Study Completion Date: September 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
olmesartan medoxomil
Drug: olmesartan medoxomil
olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Active Comparator: 2
losartan potassium
Drug: losartan potassium
losartan oral tablets, once daily for up to 12 weeks


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diastolic BP 95 mm Hg - 114 mm Hg inclusive
  • No participation in any clinical trial for the last 3 months

Exclusion Criteria:

  • Secondary hypertension
  • Malignant hypertension
  • Severe arterial hypertension
  • Significant cardiovascular disease
  • History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder
  • Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems
  Contacts and Locations
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Please refer to this study by its identifier: NCT00857285

Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
Chung Shun Medical University Hospital
Taichung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Taiwan Ltd.
  More Information

Responsible Party: Ammy Chou, Director, Daiichi Sankyo Taiwan Ltd. Identifier: NCT00857285     History of Changes
Other Study ID Numbers: TSP-866/01
Study First Received: March 5, 2009
Results First Received: May 28, 2009
Last Updated: July 22, 2009

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