Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
134 participants
INTERVENTIONAL
2015-01-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Corever middle dose
Corever
Corever
Corever high dose
Corever
Corever
Placebo
Corever
Corever
Interventions
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Corever
Corever
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
20 Years
90 Years
ALL
No
Sponsors
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TSH Biopharm Corporation Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Chern-En Chiang, M.D., Ph.D.,
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
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
Countries
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Other Identifiers
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TSHCR1201
Identifier Type: -
Identifier Source: org_study_id