Study of CS-3150 Compared to Olmesartan in Patients With Essential Hypertension

Study Overview
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Brief Summary
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Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.

Official Title
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An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: CS-3150
* Drug: olmesartan medoxomil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects aged 20 years or older at informed consent Subjects with essential hypertension during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and < 110 mmHg) Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetes mellitus with albuminuria Serum potassium level < 3.5 or ≥ 5.1 milliequivalent (mEq)/L Reversed day-night life cycle including overnight workers estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2.

Ages Eligible for Study
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Minimum Age: 20 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-3150<br>CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks | Drug: CS-3150<br>* CS-3150 2.5mg, oral<br>|
| Active Comparator: olmesartan medoxomil<br>olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks | Drug: olmesartan medoxomil<br>* olmesartan medoxomil 10 mg, oral<br>* Other names: Benicar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24 hr blood pressure | Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12 | baseline to end of Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in morning, evening, and night blood pressure. | Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and average blood pressure) and baseline factors. | baseline to week 12 | 
| Change from baseline in sitting blood pressure | Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors. | baseline to week 12 | 
| Time course of 24 hr blood pressure and sitting blood pressure | Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure) | week 12 | 
| Proportion of patients achieving 24 hr and sitting blood pressure control | Proportion of patients achieving 24 hr and sitting blood pressure control | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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essential hypertension, mineralocorticoid receptor antagonist, Developmental Phase III