Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00858702
First received: March 9, 2009
Last updated: September 18, 2009
Last verified: September 2009
Results First Received: July 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: olmesartan medoxomil and a CCB
Drug: olmesartan medoxomil and a diuretic

  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
A total of 172 patients were enrolled at 5 centers in Japan from February 12, 2005 to April 30, 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After the 4 to 6 weeks of olmesartan medoxomil monotherapy period, 105 patients who met the entry criteria for the combination therapy period were randomized to calcium channel blocker (of the dihydropyridine class) combination group or diuretic (of the thiazide class)combination group.

Reporting Groups
  Description
Olmesartan Tablets and a Calcium Channel Blocker Tablet olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
Olmesartan Medoxomil Tablets and a Diuretic Tablet olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks

Participant Flow:   Overall Study
    Olmesartan Tablets and a Calcium Channel Blocker Tablet     Olmesartan Medoxomil Tablets and a Diuretic Tablet  
STARTED     53     52  
COMPLETED     48     50  
NOT COMPLETED     5     2  
Lack of Efficacy                 1                 0  
Protocol Violation                 1                 1  
Unknown                 2                 1  
Withdrawal by Subject                 1                 0  



  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
Olmesartan Tablets and a Calcium Channel Blocker Tablet olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
Olmesartan Medoxomil Tablets and a Diuretic olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
Total Total of all reporting groups

Baseline Measures
    Olmesartan Tablets and a Calcium Channel Blocker Tablet     Olmesartan Medoxomil Tablets and a Diuretic     Total  
Number of Participants  
[units: participants]
  53     52     105  
Age  
[units: years]
Mean ± Standard Deviation
  56.2  ± 11.2     57.4  ± 9.4     56.8  ± 10.3  
Gender  
[units: participants]
     
Female     22     20     42  
Male     31     32     63  
Race/Ethnicity, Customized  
[units: Participants]
     
Japanese     53     52     105  
Region of Enrollment  
[units: participants]
     
Japan     53     52     105  



  Outcome Measures
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1.  Primary:   The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85   [ Time Frame: Baseline to week 8 ]

Measure Type Primary
Measure Title The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Measure Description No text entered.
Time Frame Baseline to week 8  
Safety Issue No  

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.
Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.

Reporting Groups
  Description
Olmesartan Tablets and a Calcium Channel Blocker Tablet olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
Olmesartan Medoxomil Tablets and a Diuretic olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks

Measured Values
    Olmesartan Tablets and a Calcium Channel Blocker Tablet     Olmesartan Medoxomil Tablets and a Diuretic  
Number of Participants Analyzed  
[units: participants]
  50     49  
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85  
[units: Percent of participants]
  34.0     59.2  


Statistical Analysis 1 for The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.0158
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No consideration for multiplicity



2.  Secondary:   Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)   [ Time Frame: At week 8 ]

Measure Type Secondary
Measure Title Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
Measure Description Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.
Time Frame At week 8  
Safety Issue Yes  

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.
Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.

Reporting Groups
  Description
Olmesartan Tablets and a Calcium Channel Blocker Tablet olmesartan medoxomil tablets and a calcium channel blocker (of the dihydropyridine class) tablet, once daily for 8 weeks
Olmesartan Medoxomil Tablets and a Diuretic olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks

Measured Values
    Olmesartan Tablets and a Calcium Channel Blocker Tablet     Olmesartan Medoxomil Tablets and a Diuretic  
Number of Participants Analyzed  
[units: participants]
  53     52  
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)  
[units: Percent of participants]
  0     7.7  


Statistical Analysis 1 for Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.0566
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No consideration for multiplicity



3.  Secondary:   Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)   [ Time Frame: At week 8 ]

Measure Type Secondary
Measure Title Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
Measure Description Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.
Time Frame At week 8  
Safety Issue Yes  

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.
Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.

Reporting Groups
  Description
Olmesartan Tablets and a Calcium Channel Blocker Tablet olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
Olmesartan Medoxomil Tablets and a Diuretic olmesartan medoxomil tablets and a diuretic tablet(of the the thiazide class) once daily for 8 weeks

Measured Values
    Olmesartan Tablets and a Calcium Channel Blocker Tablet     Olmesartan Medoxomil Tablets and a Diuretic  
Number of Participants Analyzed  
[units: participants]
  52     52  
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)  
[units: Percent of participants]
  1.9     44.2  


Statistical Analysis 1 for Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No consideration for multiplicity




  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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