Clinical trial NCT02432937: Corever in the Treatment of Hypertension
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase III Study of Corever for the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Corever
hypertension
Lead sponsor: TSH Biopharm Corporation Limited
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 134
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Seated Office SBP reduction (SBP each visit-SBP visit 2)
timeFrame: 8 weeks
Secondary outcomes:
measure: Seated Office DBP reduction (DBP each visit-DBP visit 2)
timeFrame: 8 weeks
Other outcomes:
measure: Safety-Adverse events
timeFrame: 8 weeks
measure: Safety-Changes in vital signs
timeFrame: 8 weeks
measure: Safety-Changes in laboratory examinations
timeFrame: 8 weeks
measure: Safety-Changes in electrocardiograms
timeFrame: 8 weeks
Locations:
city: Hualien
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chern-En Chiang, M.D., Ph.D.,
role: PRINCIPAL_INVESTIGATOR
References: