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An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00412932
First received: December 14, 2006
Last updated: September 15, 2009
Last verified: September 2009
Results First Received: April 28, 2009  
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/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
Participants were recruited at 37 US sites (private medical practices and small clinics) over 13 months (Nov 29,06 to Dec 28,07) from each physician’s clientele base. Approximately 200 eligible participants, men and women at least 65 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After 3-4 weeks of placebo, patients with a systolic pressure (SBP) ≥150 ≤199mmHg and diastolic pressure (DBP) ≤109 mmHg at the last 2 visits, and 8-hr daytime SBP >140 and ≤199 mmHg and DBP ≤109 mmHg by ambulatory blood pressure monitoring were entered.All started with Olmesartan 20 mg and were titrated if their blood pressure was not controlled

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 40 mg + HCTZ 25 mg if their blood pressure was not controlled.

Participant Flow for 4 periods

Period 1:   Olmesartan (Olm) 20 mg
    Active Treatment Period  
STARTED     178  
COMPLETED     171  
NOT COMPLETED     7  
Adverse Event                 1  
Lack of Efficacy                 2  
Protocol Violation                 1  
Withdrawal by Subject                 2  
Unknown                 1  

Period 2:   Olmesartan 40 mg
    Active Treatment Period  
STARTED     169 [1]
COMPLETED     161  
NOT COMPLETED     8  
Adverse Event                 4  
Lack of Efficacy                 3  
Withdrawal by Subject                 1  
[1] 171 -1 met blood pressure goal (stayed on olmesartan 20) -1 who erroneously skipped this step = 169.

Period 3:   Olm+Hydrochlorothiazide 12.5 mg
    Active Treatment Period  
STARTED     159 [1]
COMPLETED     153  
NOT COMPLETED     6  
Adverse Event                 3  
Withdrawal by Subject                 3  
[1] 161 -2 met blood pressure goal (stayed on olmesartan 40) = 159

Period 4:   Olm+ Hydrochlorothiazide 25 mg
    Active Treatment Period  
STARTED     125 [1]
COMPLETED     123  
NOT COMPLETED     2  
Adverse Event                 1  
Lost to Follow-up                 1  
[1] 153 -28 met their blood pressure goal (stayed on olmesartan 40/hydrochlorothiazide 12.5) = 125



  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 Treatment Period All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg 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 40 mg + HCTZ 25 mg if their blood pressure was not controlled.

Baseline Measures
    Active Treatment Period  
Number of Participants  
[units: participants]
  178  
Age  
[units: years]
Mean ± Standard Deviation
  72.0  ± 5.3  
Gender  
[units: participants]
 
Female     85  
Male     93  
Region of Enrollment  
[units: participants]
 
United States     178  
Baseline stage of hypertension [1]
[units: participants]
 
Stage 1 hypertension     62  
Stage 2 hypertension     116  
Baseline 24-hour ambulatory diastolic blood pressure  
[units: mm Hg]
Mean ± Standard Deviation
  80.7  ± 8.5  
Baseline 24-hour ambulatory systolic blood pressure  
[units: mm Hg]
Mean ± Standard Deviation
  149.1  ± 11.2  
Baseline diastolic blood pressure  
[units: mm Hg]
Mean ± Standard Deviation
  87.7  ± 9.6  
Baseline heart rate  
[units: beats/minute]
Mean ± Standard Deviation
  71.5  ± 11.4  
Baseline systolic blood pressure  
[units: mm Hg]
Mean ± Standard Deviation
  165.5  ± 11.9  
[1] Stage I hypertension is defined as systolic blood pressure (SBP) of 140 – 159 mmHg and diastolic blood pressure (DBP) of 90 – 99 mmHg; Stage II is defined as SBP ≥ 160 mmHg or DBP ≥ 100 mm Hg.



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment   [ Time Frame: baseline to 12 weeks ]

2.  Secondary:   Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.   [ Time Frame: baseline to 12 weeks ]

3.  Secondary:   Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment   [ Time Frame: baseline to 12 weeks ]

4.  Secondary:   Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment   [ Time Frame: baseline to 12 weeks ]

5.  Secondary:   Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment   [ Time Frame: baseline to 12 weeks ]

6.  Secondary:   Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.   [ Time Frame: baseline to 12 weeks ]

7.  Secondary:   Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.   [ Time Frame: baseline to 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
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: John Raia
Organization: Daiichi Sankyo
phone: 973-630-2683
e-mail: jraia@dsus.com


No publications provided by Daiichi Sankyo Inc.

Publications automatically indexed to this study:

Responsible Party: William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00412932     History of Changes
Other Study ID Numbers: 866-450
Study First Received: December 14, 2006
Results First Received: April 28, 2009
Last Updated: September 15, 2009
Health Authority: United States: Food and Drug Administration