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Trial record 36 of 134 for:    OLMESARTAN

Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857285
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : July 23, 2009
Last Update Posted : July 23, 2009
Daiichi Sankyo Taiwan Ltd.
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Essential Hypertension Drug: olmesartan medoxomil Drug: losartan potassium Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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
Study Start Date : May 2002
Actual Primary Completion Date : August 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Mean Change of Sitting dBP From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857285

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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.

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Responsible Party: Ammy Chou, Director, Daiichi Sankyo Taiwan Ltd. Identifier: NCT00857285     History of Changes
Other Study ID Numbers: TSP-866/01
First Posted: March 6, 2009    Key Record Dates
Results First Posted: July 23, 2009
Last Update Posted: July 23, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Olmesartan Medoxomil
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action