An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00403481
First received: November 22, 2006
Last updated: November 9, 2009
Last verified: November 2009
Results First Received: November 21, 2008  
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: Hypertension
Interventions: Drug: olmesartan medoxomil
Drug: Olmesartan medoxomil plus Hydrochlorothiazide

  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
Subjects were recruited at 24 US sites over 10 months from November 2006 to August 2007 from each physician’s clientele base. Approximately 200 eligible subjects, men and women at least 18 years of age with stage I/II hypertension and stable type 2 diabetes mellitus, were to be enrolled on active treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
192 participants started this single arm titration study. Participants remained in their group or were titrated at 3-week intervals depending on achievement their blood pressure goals.

Reporting Groups
  Description
Active Treatment Period All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.

Participant Flow for 4 periods

Period 1:   Olmesartan Medoxomil (Olm) 20 mg
    Active Treatment Period  
STARTED     192  
COMPLETED     186  
NOT COMPLETED     6  
Adverse Event                 1  
Physician Decision                 1  
Protocol Violation                 3  
Withdrawal by Subject                 1  
non-compliant                 0  
not specified                 0  
Lost to Follow-up                 0  

Period 2:   Olm 40 mg
    Active Treatment Period  
STARTED     182 [1]
COMPLETED     177  
NOT COMPLETED     5  
Adverse Event                 2  
Protocol Violation                 1  
Withdrawal by Subject                 1  
Unknown                 1  
[1] 186 -4 met their blood pressure goal (remained on olmesartan 20 mg) = 182

Period 3:   Olm 40 mg + Hydrochlorothiazide 12.5 mg
    Active Treatment Period  
STARTED     173 [1]
COMPLETED     168  
NOT COMPLETED     5  
Adverse Event                 2  
Protocol Violation                 1  
Withdrawal by Subject                 1  
Unknown                 1  
[1] 177 -4 met their blood pressure goal (remained on olmesartan 40 mg)= 173

Period 4:   Olm 40 mg + Hydrochlorothiazide 25 mg
    Active Treatment Period  
STARTED     144 [1]
COMPLETED     142  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Lost to Follow-up                 1  
[1] 168 -24 met their blood pressure goal (remained on olmesartan 40 mg/hydrochlorothiazide 12.5mg)= 144



  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
Active Treatmant Arm All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.

Baseline Measures
    Active Treatmant Arm  
Number of Participants  
[units: participants]
  192  
Age  
[units: years]
Mean ± Standard Deviation
  58.1  ± 10.3  
Gender  
[units: participants]
 
Female     85  
Male     107  
Race/Ethnicity, Customized  
[units: Participants]
 
Black/African American     43  
Asian     3  
White     145  
Native Hawaiian/Pacific Islander     1  
Region of Enrollment  
[units: participants]
 
United States     192  
Diastolic BP  
[units: mm Hg]
Mean ± Standard Deviation
  90.0  ± 10.0  
Heart rate  
[units: beats/min]
Mean ± Standard Deviation
  76.4  ± 10.4  
Systolic BP  
[units: mm Hg]
Mean ± Standard Deviation
  158.1  ± 12.6  



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.   [ Time Frame: baseline and 12 weeks ]

2.  Secondary:   Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).   [ Time Frame: baseline and 12 weeks ]

3.  Secondary:   Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.   [ Time Frame: baseline and 12 weeks ]

4.  Secondary:   Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.   [ Time Frame: baseline and 12 weeks ]

5.  Secondary:   Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.   [ Time Frame: baseline and 12 weeks ]

6.  Secondary:   Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)   [ Time Frame: baseline and 12 weeks ]

7.  Secondary:   Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12   [ Time Frame: baseline and 12 weeks ]

8.  Secondary:   Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.   [ Time Frame: baseline and 12 Weeks ]

9.  Secondary:   Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.   [ Time Frame: baseline and 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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John J. Raia, R.Ph, Pharm. D.
Organization: Daiichi Sankyo
phone: 1-877-437-7763
e-mail: druginfo@dsus.com


No publications provided by Daiichi Sankyo Inc.

Publications automatically indexed to this study:

Responsible Party: William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00403481     History of Changes
Other Study ID Numbers: 866-449
Study First Received: November 22, 2006
Results First Received: November 21, 2008
Last Updated: November 9, 2009
Health Authority: United States: Food and Drug Administration