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18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00654745
First received: April 4, 2008
Last updated: July 9, 2010
Last verified: July 2010
Results First Received: April 21, 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
Conditions: Type 2 Diabetes
Hypertension
Interventions: Drug: Amlodipine
Drug: amlodipine / olmesartan medoxomil combination
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
Subjects were recruited at 32 sites in the USA from May 12, 2008 to Jan 2, 2009 and 207 enrolled into the active treatment period. The study population consisted of subjects with controlled type 2 diabetes, not requiring insulin therapy, whose hypertension was newly diagnosed or uncontrolled on antihypertensive monotherapy or combination therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects began washout of anti-hypertensive medications during screening then entered placebo run-in lasting 2-3 weeks. Subjects must meet seated blood pressure (BP) criteria at 2 consecutive qualifying visits during the run-in period and satisfy mean daytime ambulatory BP criteria at baseline, one day prior to the first dose of active study drug.

Reporting Groups
  Description
Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required

Participant Flow:   Overall Study
    Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide  
STARTED     207 [1]
COMPLETED     164  
NOT COMPLETED     43  
Adverse Event                 12  
Lost to Follow-up                 7  
Protocol Violation                 11  
Withdrawal by Subject                 10  
poor ABPM, noncompliance, lab MAs                 3  
[1] This is single group study in which subjects were titrated to the next of 7 arms if BP goal not met.



  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
Aml + Olm + Hctz amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.

Baseline Measures
    Aml + Olm + Hctz  
Number of Participants  
[units: participants]
  207  
Age  
[units: years]
Mean ± Standard Deviation
  59.1  ± 9.50  
Gender  
[units: participants]
 
Female     122  
Male     85  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     54  
Not Hispanic or Latino     153  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     8  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     35  
White     162  
More than one race     0  
Unknown or Not Reported     0  
Stage of hypertension [1]
[units: participants]
 
Stage 1     115  
Stage 2     92  
Body mass index  
[units: mg/m2]
Mean ± Standard Deviation
  32.80  ± 5.947  
Mean 24-hour ambulatory diastolic blood pressure  
[units: mm Hg]
Mean ± Standard Deviation
  81.6  ± 9.76  
Mean 24-hour ambulatory systolic blood pressure  
[units: mm Hg]
Mean ± Standard Deviation
  144.4  ± 11.74  
Pulse rate  
[units: beats per minute]
Mean ± Standard Deviation
  73.75  ± 11.909  
Seated Diastolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  89.1  ± 10.13  
Seated Systolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  158.8  ± 13.14  
Years with diabetes  
[units: years]
Mean ± Standard Deviation
  6.44  ± 5.978  
[1] Stage 1 or Stage 2 Hypertension. Stage 1 = Blood pressure > 140/90 mm Hg. Stage 2 = systolic >160 mm Hg or diastolic > 100 mm Hg



  Outcome Measures
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1.  Primary:   Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment   [ Time Frame: week 0 - week 12 ]

2.  Secondary:   Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment   [ Time Frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour) ]

3.  Secondary:   Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment   [ Time Frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour) ]

4.  Secondary:   Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks   [ Time Frame: week 0 - weeks 3, 6, 9, 12, 15, 18 ]

5.  Secondary:   Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks   [ Time Frame: week 0 - weeks 3, 6, 9, 12, 15, 18 ]

6.  Secondary:   Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12   [ Time Frame: week 0 - week 12 ]

7.  Secondary:   Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12   [ Time Frame: week 0 - week 12 ]

8.  Secondary:   Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12   [ Time Frame: week 0 - week 12 ]

9.  Secondary:   Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12   [ Time Frame: week 0 - week 12 ]

10.  Secondary:   Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12   [ Time Frame: week 0 - week 12 ]

11.  Secondary:   Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12   [ Time Frame: week 0 - week 12 ]

12.  Secondary:   Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3   [ Time Frame: week 0 - week 3 ]

13.  Secondary:   Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6   [ Time Frame: week 0 - week 6 ]

14.  Secondary:   Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9   [ Time Frame: week 0 - week 9 ]

15.  Secondary:   Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12   [ Time Frame: week 0 - week 12 ]

16.  Secondary:   Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15   [ Time Frame: week 0 - week 15 ]

17.  Secondary:   Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18   [ Time Frame: week 0 - week 18 ]

18.  Secondary:   Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12   [ Time Frame: week 0 - week 12 ]

19.  Secondary:   Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12   [ Time Frame: week 0 - week 12 ]

20.  Secondary:   Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12   [ Time Frame: week 0 - week 12 ]

21.  Secondary:   Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12   [ Time Frame: week 0 - week 12 ]

22.  Secondary:   Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions   [ Time Frame: week 0 - week 12 ]

23.  Secondary:   Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12   [ Time Frame: week 0 - week 12 ]

24.  Secondary:   Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3   [ Time Frame: week 0 - week 3 ]

25.  Secondary:   Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6   [ Time Frame: week 0 - week 6 ]

26.  Secondary:   Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9   [ Time Frame: week 0 - week 9 ]

27.  Secondary:   Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12   [ Time Frame: week 0 - week 12 ]

28.  Secondary:   Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15   [ Time Frame: week 0 - week 15 ]

29.  Secondary:   Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18   [ Time Frame: week 0 - week 18 ]


  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
No text entered.


  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: James McCarthy
Organization: Daiichi Sankyo
phone: 732-590-3430
e-mail: jmccarthy@dsi.com


No publications provided


Responsible Party: Director, Medical Research, Hypertension, Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00654745     History of Changes
Other Study ID Numbers: CS-8663-403
Study First Received: April 4, 2008
Results First Received: April 21, 2010
Last Updated: July 9, 2010
Health Authority: United States: Food and Drug Administration