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

Study Overview
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Brief Summary
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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

Official Title
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Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone

Conditions
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Hypertension

Intervention / Treatment
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* Drug: olmesartan medoxomil and a CCB
* Drug: olmesartan medoxomil and a diuretic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks | Drug: olmesartan medoxomil and a CCB<br>* olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks<br>|
| Experimental: 2<br>olmesartan medoxomil and a diuretic tablet (of the thiazide class) | Drug: olmesartan medoxomil and a diuretic<br>* olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 |  | Baseline to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At week 8 | 
| 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. | At week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential hypertension, Combination therapy