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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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