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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
olmesartan medoxomil
losartan potassium
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

olmesartan medoxomil

losartan potassium

Outcomes

Primary Outcome Measures

Change of trough seated diastolic blood pressure from baseline to 8 weeks

Secondary Outcome Measures

Full Information

First Posted
March 3, 2009
Last Updated
September 28, 2010
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Shanghai Sankyo Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00856271
Brief Title
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Shanghai Sankyo Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
olmesartan medoxomil
Arm Title
2
Arm Type
Active Comparator
Arm Description
losartan potassium
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
oral tablets, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
losartan potassium
Intervention Description
capsules, once daily for 8 weeks
Primary Outcome Measure Information:
Title
Change of trough seated diastolic blood pressure from baseline to 8 weeks
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vice President
Organizational Affiliation
Sankyo Shanghai Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Beijing
Country
China
City
Chongqing
Country
China
City
Guang Zhou
Country
China
City
Nanjing
Country
China
City
Shanghai
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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