Hypertension
Conditions
Keywords
Corever, hypertension
Brief summary
The study primarily aims to compare the effects of two doses of Corever with placebo in patients with hypertension.
Detailed description
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.
Interventions
DRUGCorever
Corever
Sponsors
TSH Biopharm Corporation Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are 20-90 years of age 2. 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. 3. Agree to and are able to follow the study procedures. 4. Understand the nature of the study, and have signed informed consent forms.
Exclusion criteria
1. 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. 2. Patients with clinically significant abnormalities. 3. Patients with known contraindication to Corever. 4. Female patients who are pregnant or lactating. 5. 5\. Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study. 6. Patients is currently participating in any other clinical trial within 30 days 7. Patients need to be treated with the permitted medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seated Office SBP reduction (SBP each visit-SBP visit 2) | 8 weeks | To compare the change in office SBP measurements by cuff assessments after 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seated Office DBP reduction (DBP each visit-DBP visit 2) | 8 weeks | 1. To compare the change in office DBP measurements by cuff assessments after 8 weeks of treatment 2. To compare the percentage of subjects who achieve BP goal as measured by cuff assessments (140/90 mmHg) after 8 weeks of treatment |
Other
| Measure | Time frame |
|---|---|
| Safety-Adverse events | 8 weeks |
| Safety-Changes in vital signs | 8 weeks |
| Safety-Changes in laboratory examinations | 8 weeks |
| Safety-Changes in electrocardiograms | 8 weeks |
Countries
Taiwan
Outcome results
None listed