Use of the 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 Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
* Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets
* Drug: olmesartan medoxomil/hydrochlorothiazide tablets
* Drug: olmesartan medoxomil/hydrochlorothiazide tablets


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 hypertension (HTN) 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: 4<br>olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo<br>* olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week<br>|
| Experimental: 1<br>olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | Drug: olmesartan medoxomil/hydrochlorothiazide tablets<br>* olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks<br>|
| Experimental: 3<br>olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | Drug: olmesartan medoxomil/hydrochlorothiazide tablets<br>* olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks<br>|
| Experimental: 2<br>olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets<br>* olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo 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 |
| --- | --- | --- |
| Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16 | Change = Week 16 - Week 8 (baseline). | 8 weeks, change = week 16 - week 8 | 

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 = week 12 - week 8 | 
| Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16. | Change = Week 16 - Week 8 (baseline). | 8 weeks, change = week 16 - week 8 | 
| Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12. | Change = Week 12 - Week 8 (baseline). | 4 weeks, change = week 12 - week 8 | 
| Number of Patients Achieving Target Blood Pressure at Week 16 | Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics | 8 weeks | 
| Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. | Change = Week 16 - Week 8 (baseline). | 8 weeks, change = week 16 - week 8 | 
| Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. | Change = Week 16 - Week 8 (baseline). | 8 weeks, change = week 16 - week 8 | 
| Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. | Change = Week 16 - Week 8 (baseline). | 8 weeks, change = week 16 - week 8 | 

 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