Corever in the Treatment of Hypertension

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TSH Biopharm Corporation Limited

Criteria

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.