Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension

Study Overview
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Brief Summary
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This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

Official Title
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Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients age greater than or equal to 18 years with mild to moderate hypertension. Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough. Exclusion Criteria: Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception. Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases. Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack. Patients with clinically significant elevations in laboratory values at Screening Visit. Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome. Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks | Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary<br>* Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved. | For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg. | Baseline to ≤20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved | Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients. | Baseline to ≤20 weeks | 
| Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved. | Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough. | Baseline to ≤20 weeks | 
| Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved | Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough | Baseline to ≤20 weeks | 
| Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment |  | Baseline to ≤20 weeks | 
| Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment |  | Baseline to ≤20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olmesartan medoxomil, Hypertension