NCT02432937

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Jan 2015

Typical duration for phase_3 hypertension

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

1.4 years

First QC Date

January 29, 2015

Last Update Submit

November 2, 2016

Conditions

Hypertension

Keywords

Coreverhypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Seated Office DBP reduction (DBP each visit-DBP visit 2)

    8 weeks

Other Outcomes (4)

  • Safety-Adverse events

    8 weeks

  • Safety-Changes in vital signs

    8 weeks

  • Safety-Changes in laboratory examinations

    8 weeks

  • +1 more other outcomes

Study Arms (3)

Corever middle dose

PLACEBO COMPARATOR
Drug: Corever

Corever high dose

PLACEBO COMPARATOR
Drug: Corever

Placebo

PLACEBO COMPARATOR
Drug: Corever

Interventions

CoreverDRUG

Corever

Also known as: CRTA04
Corever high doseCorever middle dosePlacebo

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are 20-90 years of age
  • 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.
  • Agree to and are able to follow the study procedures.
  • Understand the nature of the study, and have signed informed consent forms.

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Chern-En Chiang, M.D., Ph.D.,

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

May 4, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

TW(8)