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Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
This study has been completed.
Study NCT00649389   Information provided by Daiichi Sankyo Inc.

First Received on March 28, 2008.   Last Updated on August 31, 2010   History of Changes
Results First Received: August 9, 2010  
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: Hypertension
Interventions: Drug: Olmesartan medoxomil
Drug: Amlodipine
Drug: 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
First subject first visit 12 May 2008. Last subject last follow-up 27 Feb 2009. 317 sites in USA and Puerto Rico. Planned: 2400 subjects (600 per treatment arm). Enrolled: 6724 subjects. Randomized: 2492 subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Duration of the study was 57 weeks with 52 weeks of treatment. This included 3-week stabilization/washout (Period I), 12-week double blind treatment (Period II), 40 week open label treatment (Period III), and 2-week post treatment follow-up (Period IV).

Reporting Groups
  Description
OM40/AML10 Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
OM40/HCTZ25 Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
AML10/HCTZ25 Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
OM40/AML10/HCTZ25 Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.

Participant Flow:   Overall Study
    OM40/AML10     OM40/HCTZ25     AML10/HCTZ25     OM40/AML10/HCTZ25  
STARTED     628     637     600     627  
COMPLETED     557     531     512     516  
NOT COMPLETED     71     106     88     111  
Adverse Event                 22                 46                 38                 48  
Lost to Follow-up                 15                 17                 21                 26  
Protocol Violation                 11                 13                 9                 8  
Withdrawal by Subject                 20                 21                 19                 23  
unknown                 3                 9                 1                 6  



  Baseline Characteristics
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Reporting Groups
  Description
OM40/AML10 Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
OM40/HCTZ25 Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
AML10/HCTZ25 Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
OM40/AML10/HCTZ25 Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.

Baseline Measures
    OM40/AML10     OM40/HCTZ25     AML10/HCTZ25     OM40/AML10/HCTZ25     Total  
Number of Participants  
[units: participants]
  628     637     600     627     2492  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     508     505     504     504     2021  
>=65 years     120     132     96     123     471  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 10.93     55.9  ± 10.78     54.6  ± 10.82     54.7  ± 11.22     55.1  ± 10.94  
Gender  
[units: participants]
         
Female     303     298     266     307     1174  
Male     325     339     334     320     1318  
Race/Ethnicity, Customized [1]
[units: Participants]
         
American Indian/Alaskan Native     3     1     4     1     9  
Asian     13     10     7     19     49  
Hawaiian/Pacific Islander     0     1     1     2     4  
Black/African American     181     200     192     184     757  
White     431     421     391     415     1658  
Unknown or Not Reported     0     4     5     6     15  
Diabetes Status  
[units: Participants]
         
Diabetic     100     99     92     96     387  
Not diabetic     528     538     508     531     2105  
Weight  
[units: kg]
Mean ± Standard Deviation
  95.9  ± 22.65     96.1  ± 22.55     96.1  ± 23.41     96.0  ± 23.24     96.0  ± 22.94  
Body Mass Index  
[units: Participants]
         
Less than 30 kg/m2     229     238     230     240     937  
Greater than or equal to 30 kg/m2     399     399     370     387     1555  
Duration of hypertension  
[units: years]
Mean ± Standard Deviation
  10.12  ± 9.865     10.34  ± 9.826     9.73  ± 8.983     9.54  ± 9.558     9.94  ± 9.571  
[1] Race of participants as selected by participant. Participants were allowed to choose more than one race category; therefore, the total for an arm may be greater than the number of participants



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).   [ Time Frame: baseline to 12 weeks ]

2.  Secondary:   Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks   [ Time Frame: Baseline to 12 weeks ]

3.  Secondary:   Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination   [ Time Frame: Baseline to 12 weeks or early termination ]

4.  Secondary:   Change in Seated Systolic Blood Pressure From Baseline to Week 12   [ Time Frame: Baseline to week 12 ]


  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 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.


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
phone: 732-590-5032
e-mail: hmkessler@dsi.com


No publications provided by Daiichi Sankyo Inc.

Publications automatically indexed to this study:

Responsible Party: Executive Director Clinical Development, Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00649389     History of Changes
Other Study ID Numbers: CS8635-A-U301
Study First Received: March 28, 2008
Results First Received: August 9, 2010
Last Updated: August 31, 2010
Health Authority: United States: Food and Drug Administration