Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone
1 other identifier
interventional
105
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
Started Feb 2005
Shorter than P25 for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 9, 2009
CompletedFirst Posted
Study publicly available on registry
March 10, 2009
CompletedResults Posted
Study results publicly available
August 26, 2009
CompletedOctober 11, 2017
October 1, 2017
5 months
March 9, 2009
July 16, 2009
October 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Baseline to week 8
Secondary Outcomes (2)
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
At week 8
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
At week 8
Study Arms (2)
1
EXPERIMENTALolmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks
2
EXPERIMENTALolmesartan medoxomil and a diuretic tablet (of the thiazide class)
Interventions
olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with secondary hypertension
- Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Howard Kessler
- Organization
- Daiichi Sankyo
Study Officials
- STUDY DIRECTOR
Research and Development Division
Daiichi Sankyo Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 9, 2009
First Posted
March 10, 2009
Study Start
February 1, 2005
Primary Completion
July 1, 2005
Study Completion
November 1, 2005
Last Updated
October 11, 2017
Results First Posted
August 26, 2009
Record last verified: 2017-10