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

This study has been completed.
Sponsor:
Collaborator:
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00856271
First received: March 3, 2009
Last updated: September 28, 2010
Last verified: September 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 3, 2009
Last Updated: September 28, 2010
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013