NCT04521023

Brief Summary

Phase 4 clinical trial to Evaluate the blood pressure lowering effect of a Candesartan/Hydrochlorothiazide(Candemore Plus Tab) versus Candesartan/Amlodipine(Cantabell Tab) in Hypertensive Patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Sep 2017

Typical duration for phase_4 hypertension

Geographic Reach
1 country

14 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

September 20, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

August 18, 2020

Last Update Submit

August 18, 2020

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • cSBP(central Systolic Blood Pressure)

    Average cSBP change after 8 weeks compared to baseline

    change after 8 weeks compared to baseline

Secondary Outcomes (3)

  • cDBP(central Diastolic Blood Pressure)

    change after 8 weeks compared to baseline

  • sitSBP(sitting Systolic Blood Pressure)

    change after 8 weeks compared to baseline

  • sitDBP(sitting Diastolic Blood Pressure)

    change after 8 weeks compared to baseline

Study Arms (2)

A

EXPERIMENTAL
Drug: Cantabell Tab

B

ACTIVE COMPARATOR
Drug: Candemore Plus Tab

Interventions

Cantabell TabDRUG

Patients assigned to experimental group are treated with Cantabell Tab

A
Candemore Plus TabDRUG

Patients assigned to experimental group are treated with Candemore Plus Tab

B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 19 years old
  • Agreement with written informed consent
  • Hypertensive Patients

You may not qualify if:

  • Patients with secondary hypertension
  • Participated in other trial within 30 days
  • In investigator's judgement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Location

Hallym Univ. Medical Center

Anyang, South Korea

Location

Daegu Catholic Univ. Medical Center

Daegu, South Korea

Location

MYONGJI Hospital

Goyang-si, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan-gu, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Hanyang University Medical Center

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

SNU Boramae Medical Center

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Tablets

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 20, 2020

Study Start

September 20, 2017

Primary Completion

January 28, 2020

Study Completion

June 3, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(14)