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Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857285
First Posted: March 6, 2009
Last Update Posted: July 29, 2009
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.
Collaborator:
Daiichi Sankyo Taiwan Ltd.
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00857285


Locations
Taiwan
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.
ClinicalTrials.gov Identifier: NCT00857285     History of Changes
Other Study ID Numbers: TSP-866/01
First Submitted: March 5, 2009
First Posted: March 6, 2009
Results First Submitted: May 28, 2009
Results First Posted: July 23, 2009
Last Update Posted: July 29, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Olmesartan
Olmesartan Medoxomil
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action