Full Text View
Tabular View
Study Results
Related Studies
Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension (OLMETREAT)
This study has been completed.
Study NCT00311155   Information provided by Daiichi Sankyo Inc.

First Received on April 3, 2006.   Last Updated on November 23, 2010   History of Changes
Results First Received: October 12, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Essential Hypertension
Intervention: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted between April 2006 and April 2008 in 9 European countries at 58 investigational sites. The countries participating were: Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Switzerland, and United Kingdom.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.

Participant Flow:   Overall Study
    Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed  
STARTED     694  
COMPLETED     601 [1]
NOT COMPLETED     93  
Adverse Event                 21  
Withdrawal by Subject                 17  
Did not meet entry criteria                 55  
[1] Some participants had multiple reasons for discontinuation



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.

Baseline Measures
    Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed  
Number of Participants  
[units: participants]
  694  
Age  
[units: years]
Mean ± Standard Deviation
  58.16  ± 12.06  
Gender  
[units: participants]
 
Female     337  
Male     357  
Region of Enrollment  
[units: participants]
 
Portugal     12  
France     121  
Belgium     94  
Austria     35  
Netherlands     43  
Germany     207  
United Kingdom     141  
Italy     35  
Switzerland     6  
Weight  
[units: kg]
Mean ± Standard Deviation
  82.16  ± 16.09  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  28.86  ± 4.69  
Ethnicity  
[units: Participants]
 
Caucasian     678  
Black     13  
Asian     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.   [ Time Frame: Baseline to ≤20 weeks ]

2.  Secondary:   Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved   [ Time Frame: Baseline to ≤20 weeks ]

3.  Secondary:   Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.   [ Time Frame: Baseline to ≤20 weeks ]

4.  Secondary:   Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved   [ Time Frame: Baseline to ≤20 weeks ]

5.  Secondary:   Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment   [ Time Frame: Baseline to ≤20 weeks ]

6.  Secondary:   Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment   [ Time Frame: Baseline to ≤20 weeks ]


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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
No text entered.  


Results Point of Contact:  
Name/Title: Sr. Director, Regulatory Operations
Organization: Daiichi Sankyo Pharma Development
phone: 732-590-5032
e-mail: hmkessler@dsi.com


No publications provided


Responsible Party: Senior Manager - Study Coordination, Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00311155     History of Changes
Other Study ID Numbers: SP-OLM-03-05, 2005-004659-36
Study First Received: April 3, 2006
Results First Received: October 12, 2010
Last Updated: November 23, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices