Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857285
• Other study ID #: TSP-866/01
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2009
• Last updated: July 22, 2009
• Start date: May 2002
• Est. completion date: September 2003

Study information

• Verified date: July 2009
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• olmesartan medoxomil
olmesartan medoxomil oral tablets, once daily for up to 12 weeks
• losartan potassium
losartan oral tablets, once daily for up to 12 weeks

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Chung Shun Medical University Hospital	Taichung City
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.	Daiichi Sankyo Taiwan Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change of Sitting dBP From Baseline to Week 12		Baseline to 12 weeks	No