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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 
Other                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 
Overall Participants Analyzed 
[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 ]

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

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


  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 NOT 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.


Results Point of Contact:  
Name/Title: Howard Kessler
Organization: Daiichi Sankyo
phone: 732-590-5032
e-mail: hmkessler@dsi.com



Responsible Party: Yoshihiro Kakehi, Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT00858702     History of Changes
Other Study ID Numbers: OLM004-071
Study First Received: March 9, 2009
Results First Received: July 16, 2009
Last Updated: September 18, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare