Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

This study has been completed.

Sponsor:

Collaborator:

Daiichi Sankyo Taiwan Ltd.

Information provided by:

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00857285

First received: March 5, 2009

Last updated: July 22, 2009

Last verified: July 2009

History of Changes

Results First Received: May 28, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Essential Hypertension
Interventions:	Drug: olmesartan medoxomil Drug: losartan potassium

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 181 subjects were screened at 3 study sites in Taiwan from May 2002 to April 2003, and 51 subjects had dropped as screen failure.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a taper off period for 1 week, if necessary, and a placebo run-in period for 2 weeks, 130 subjects were randomized to olmesartan 20mg and losartan 50mg by 1:1 ratio.

Reporting Groups

	Description
Olmesartan Medoxomil	olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Losartan Potassium	losartan potassium oral tablets, once daily for up to 12 weeks

Participant Flow: Overall Study

	Olmesartan Medoxomil	Losartan Potassium
STARTED	65	65
COMPLETED	53	59
NOT COMPLETED	12	6
Adverse Event	4	2
Lack of Efficacy	0	2
Protocol Violation	3	1
Withdrawal by Subject	4	0
Randomization criteria not met	1	1

Baseline Characteristics

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Reporting Groups

	Description
Olmesartan Medoxomil	olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Losartan Potassium	losartan potassium oral tablets, once daily for up to 12 weeks
Total	Total of all reporting groups

Baseline Measures

	Olmesartan Medoxomil	Losartan Potassium	Total
Number of Participants [units: participants]	65	65	130
Age [units: years] Mean ± Standard Deviation	49.63 ± 10.69	48.34 ± 9.17	48.98 ± 9.94
Gender [units: participants]
Female	33	23	56
Male	32	42	74
Race/Ethnicity, Customized [units: participants]
Taiwanese	65	65	130
Region of Enrollment [units: participants]
Taiwan	65	65	130

Outcome Measures

1. Primary:

Mean Change of Sitting dBP From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Senior Director, Regulatory Operations
Organization: Daiichi Sankyo, Inc.
phone: 732-590-5000
e-mail: hmkessler@dsus.com

No publications provided

Responsible Party:	Ammy Chou, Director, Daiichi Sankyo Taiwan Ltd.
ClinicalTrials.gov Identifier:	NCT00857285 History of Changes
Other Study ID Numbers:	TSP-866/01
Study First Received:	March 5, 2009
Results First Received:	May 28, 2009
Last Updated:	July 22, 2009
Health Authority:	Taiwan: Department of Health

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