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

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00856271
• Collaborator: Shanghai Sankyo Pharmaceuticals Co., Ltd. (Other)
• Enrollment: 287
• Locations: 5
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 57.4
• Patients Per Site Per Month: 7.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: olmesartan medoxomil; Drug: losartan potassium	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 287 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Feb 1, 2005
• Actual Study Completion Date: Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change of trough seated diastolic blood pressure from baseline to 8 weeks [Baseline to 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Beijing		China
2		Chongqing		China
3		Guang Zhou		China
4		Nanjing		China
5		Shanghai		China

Sponsors and Collaborators

• Daiichi Sankyo, Inc.
• Shanghai Sankyo Pharmaceuticals Co., Ltd.

Investigators

• Study Director: Vice President, Sankyo Shanghai Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00856271
• Other Study ID Numbers: SS-866/01
• First Posted: Mar 5, 2009
• Last Update Posted: Sep 29, 2010
• Last Verified: Sep 1, 2010

• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Losartan; Olmesartan; Olmesartan Medoxomil

Study Results

No Results Posted as of Sep 29, 2010