Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
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
1 other identifier
interventional
130
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2002
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedResults Posted
Study results publicly available
July 23, 2009
CompletedJuly 23, 2009
July 1, 2009
1.3 years
March 5, 2009
May 28, 2009
July 22, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 12 weeks
Study Arms (2)
1
EXPERIMENTALolmesartan medoxomil
2
ACTIVE COMPARATORlosartan potassium
Interventions
Eligibility Criteria
You may qualify if:
- Diastolic BP 95 mm Hg - 114 mm Hg inclusive
- No participation in any clinical trial for the last 3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Daiichi Sankyo Taiwan Ltd.collaborator
Study Sites (3)
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Chung Shun Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Regulatory Operations
- Organization
- Daiichi Sankyo, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
May 1, 2002
Primary Completion
August 1, 2003
Study Completion
September 1, 2003
Last Updated
July 23, 2009
Results First Posted
July 23, 2009
Record last verified: 2009-07