Corever in the Treatment of Hypertension

Study Overview
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Brief Summary
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The study primarily aims to compare the effects of two doses of Corever with placebo in patients with hypertension.

Detailed Description
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The study aims to compare the effects of two doses of Corever with placebo in patients with essential hypertension. Eligible subjects who belong to one of the following subtypes are planned to be enrolled: (1) patients with essential hypertension without drug control, or (2) uncontrolled hypertension despite treatment with up to 2 antihypertensive agents. Of note, the second category will receive randomized study treatments in addition to continuing their previous medication throughout the trial. The study also wants to investigate the safety profile of Corever during treatment period.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase III Study of Corever for the Treatment of Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Corever


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 20-90 years of age Patients who belong to either one of the following categories: With essential hypertension, as measured by office BP and are not on antihypertensive treatment at screening . With uncontrolled hypertension despite treatment with up to 2 antihypertensive agents, and the type and dose of the agents shall be maintained for at least 28 days prior to entering this trial. Agree to and are able to follow the study procedures. Understand the nature of the study, and have signed informed consent forms. Exclusion Criteria: Patients with any of the following conditions: Malignant hypertension Secondary hypertension Average sitting SBP ≥ 180 mmHg Advanced hypertensive retinopathy Type 1 diabetes Acute coronary syndrome Clinical significant valvular disease Hypertrophic cardiomyopathies New York Heart Association class III -IV congestive HF Second or third degree atrioventricular block or history of sick sinus syndrome unless a pacemaker is in place Atrial fibrillation Sinus bradycardia (<60 bpm) Asthma Stroke within 3 months Cancer with expected survival less than 3 years A difference of > 20 mmHg for SBP or > 10 mmHg for DBP between arms at screening Severe hepatic impairment A history of a serious hypersensitivity reaction. Patients with clinically significant abnormalities. Patients with known contraindication to Corever. Female patients who are pregnant or lactating. 5. Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study. Patients is currently participating in any other clinical trial within 30 days Patients need to be treated with the permitted medication.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Placebo Comparator: Corever middle dose<br> | Drug: Corever<br>* Corever<br>* Other names: CRTA04;|
| Placebo Comparator: Corever high dose<br> | Drug: Corever<br>* Corever<br>* Other names: CRTA04;|
| Placebo Comparator: Placebo<br> | Drug: Corever<br>* Corever<br>* Other names: CRTA04;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seated Office SBP reduction (SBP each visit-SBP visit 2) | To compare the change in office SBP measurements by cuff assessments after 8 weeks of treatment | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seated Office DBP reduction (DBP each visit-DBP visit 2) | To compare the change in office DBP measurements by cuff assessments after 8 weeks of treatment To compare the percentage of subjects who achieve BP goal as measured by cuff assessments (140/90 mmHg) after 8 weeks of treatment | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corever, hypertension