Corever in the Treatment of Hypertension

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase III Study of Corever for the Treatment of Hypertension

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Corever

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Hualien, Taiwan
    • Hualien Tzu Chi Hospital
  • Kaohsiung, Taiwan
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taichung, Taiwan
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taipei, Taiwan
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Corever; Corever; Other Names: CRTA04
Placebo Comparator: Corever middle dose	Drug: Corever; Corever; Other Names: CRTA04
Placebo Comparator: Corever high dose	Drug: Corever; Corever; Other Names: CRTA04

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seated Office SBP reduction (SBP each visit-SBP visit 2)	To compare the change in office SBP measurements by cuff assessments after 8 weeks of treatment	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seated Office DBP reduction (DBP each visit-DBP visit 2)	To compare the change in office DBP measurements by cuff assessments after 8 weeks of treatment; To compare the percentage of subjects who achieve BP goal as measured by cuff assessments (140/90 mmHg) after 8 weeks of treatment	8 weeks

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: TSH Biopharm Corporation Limited
• Investigators: Principal Investigator: Chern-En Chiang, M.D., Ph.D.,, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimate): May 4, 2015

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: hypertension; Corever
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: TSHCR1201