Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
olmesartan medoxomil and a CCB
olmesartan medoxomil and a diuretic
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Essential hypertension, Combination therapy
Eligibility Criteria
Inclusion Criteria:
- Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
- Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil
Exclusion Criteria:
- Patients with secondary hypertension
- Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks
olmesartan medoxomil and a diuretic tablet (of the thiazide class)
Outcomes
Primary Outcome Measures
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Secondary Outcome Measures
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
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.
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
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.
Full Information
NCT ID
NCT00858702
First Posted
March 9, 2009
Last Updated
October 10, 2017
Sponsor
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00858702
Brief Title
Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
Official Title
Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Essential hypertension, Combination therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
olmesartan medoxomil and a diuretic tablet (of the thiazide class)
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil and a CCB
Intervention Description
olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil and a diuretic
Intervention Description
olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
Primary Outcome Measure Information:
Title
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Time Frame
Baseline to week 8
Secondary Outcome Measure Information:
Title
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
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
Title
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil
Exclusion Criteria:
Patients with secondary hypertension
Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Research and Development Division
Organizational Affiliation
Daiichi Sankyo Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
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