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Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Taiwan
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

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

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

Sites / Locations

  • Kaohsiung Medical University Hospital
  • Chung Shun Medical University Hospital
  • National Taiwan University Hospital

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

Mean Change of Sitting dBP From Baseline to Week 12
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2009
Last Updated
July 22, 2009
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Taiwan Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00857285
Brief Title
Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Taiwan Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (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
olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
losartan potassium
Intervention Description
losartan oral tablets, once daily for up to 12 weeks
Primary Outcome Measure Information:
Title
Mean Change of Sitting dBP From Baseline to Week 12
Description
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Chung Shun Medical University Hospital
City
Taichung City
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

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