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Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension (Benibest)
This study has been completed.
Study NCT00890591   Information provided by Daiichi Sankyo Inc.
Study First Received: February 11, 2009   Last Updated: May 27, 2009   History of Changes
Results First Received: February 11, 2009  
Study Type: Interventional
Study Design: Control: Uncontrolled, 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
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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
The study pop. was defined by the inclusion criteria. This study was carried out in 14 centers in Brazil with inclusion 2 months after the first study subject, started in Aug 06. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. The last patient out was in Jul 07.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A wash out period was needed in case of a previous inefficient antihypertensive medication, so it was interrupted from 2 to 3 wks before the enrollment. The patient could be excluded considering the exclusion criteria.

Reporting Groups
  Description
Olmesartan + Hydrochlorothiazide + Amlodipine
  1. olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.
  2. olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved
  3. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved
  4. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved

Participant Flow:   Overall Study
  Olmesartan + Hydrochlorothiazide + Amlodipine
STARTED   144  
COMPLETED   124  
NOT COMPLETED   20  
      Lack of Efficacy               20  



  Baseline Characteristics
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Reporting Groups
  Description
Olmesartan + Hydrochlorothiazide + Amlodipine
  1. olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.
  2. olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved
  3. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved
  4. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved

Baseline Measures
  Olmesartan + Hydrochlorothiazide + Amlodipine
Number of Participants  
[units: participants]
144
Age  
[units: participants]
 
<=18 years 0
Between 18 and 65 years 132
>=65 years 12
Gender  
[units: participants]
 
Female 74
Male 70
Race/Ethnicity, Customized  
[units: Participants]
 
Black 24
White 83
Asian 7
Other 30
Region of Enrollment  
[units: participants]
 
Brazil 144



  Outcome Measures
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1.  Primary:   Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)   [ Time Frame: 4 - 9 wks of olmesartan monotherapy ]

2.  Primary:   Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)   [ Time Frame: 4 to 9 weeks on combination therapy ]

3.  Primary:   Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)   [ Time Frame: 4 to 9 weeks ]

4.  Primary:   Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)   [ Time Frame: 4 - 9 weeks ]


  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
No text entered.  


Results Point of Contact:  
Name/Title: Howard Kessler
Organization: Daiichi Sankyo Pharma Development
phone: 732-590-5032
e-mail: hmkessler@dsus.com


No publications provided


Responsible Party: Daiichi Sankyo Brazil ( Medical Affairs Manager )
Study ID Numbers: SPB-OM-0106
Study First Received: February 11, 2009
Results First Received: February 11, 2009
Last Updated: May 27, 2009
ClinicalTrials.gov Identifier: NCT00890591     History of Changes
Health Authority: Brazil: Ethics Committee