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The study primarily aims to compare the effects of two doses of Corever with placebo in patients with hypertension.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corever middle dose | Placebo Comparator |
| |
| Corever high dose | Placebo Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corever | Drug | Corever |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seated Office DBP reduction (DBP each visit-DBP visit 2) |
| 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety-Adverse events | 8 weeks | |
| Safety-Changes in vital signs | 8 weeks | |
| Safety-Changes in laboratory examinations |
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Chern-En Chiang, M.D., Ph.D., | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hualien Tzu Chi Hospital | Hualien City | Taiwan | ||||
| Kaohsiung Chang Gung Memorial Hospital |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 8 weeks |
| Safety-Changes in electrocardiograms | 8 weeks |
| Kaohsiung City |
| Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| Chung Shan Medical University Hospital | Taichung | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |