Corever in the Treatment of Hypertension

TSH Biopharm

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Corever

Study type: Interventional

Funder types: Industry

Identifiers

NCT02432937

TSHCR1201

Details and patient eligibility

About

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

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 3 patient groups, including a placebo group

Corever middle dose

Placebo Comparator group

Treatment:

Drug: Corever

Corever high dose

Placebo Comparator group

Treatment:

Drug: Corever

Placebo

Placebo Comparator group

Treatment:

Drug: Corever