Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Study Overview
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Brief Summary
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The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.

Official Title
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Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
* Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements) Exclusion Criteria: Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period. Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases. Patients having a history of the following within the last six months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, severe heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke) or transient ischaemic attack. Patients with clinically significant abnormal laboratory values at screening. Patients with secondary HTN.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo | Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets<br>* olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks<br>|
| Experimental: 2<br>olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo | Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg<br>* olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Trough Sitting Diastolic Blood Pressure | Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 | Change = Week 12 - Week 8 (baseline). | 4 weeks | 
| Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. | 4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline). | 8 weeks | 
| Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. | Change = Week 16 - Week 8 (baseline). | 8 weeks | 
| Number of Participants Achieving Blood Pressure Goal. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate-to-Severe Hypertension, Essential Hypertension, Combination Therapy, Fixed-Combination Dose