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

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ClinicalTrials.gov Identifier: NCT00856271
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : September 29, 2010
Sponsor:
Collaborator:
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Information provided by:
Daiichi Sankyo, Inc.

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
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
Study Start Date : August 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : April 2005


Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00856271


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

Responsible Party: Naotaka Ikegami, Vice President, Shanghai Sankyo Pharmaceuticals, Co., Ltd.
ClinicalTrials.gov Identifier: NCT00856271     History of Changes
Other Study ID Numbers: SS-866/01
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: September 29, 2010
Last Verified: September 2010

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