A Clinical Trial to Evaluate the Blood Pressure Lowering Effect of a Candemore Plus Tab Versus Cantabell Tab in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

A Randomized, Double-blind, Non-inferiority, Multi-center, Phase 4 Trial to Evaluate the Blood Pressure Lowering Effect of a Candesartan/Hydrochlorothiazide(Candemore Plus® Tab) Versus Candesartan/Amlodipine(Cantabell® Tab) in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Cantabell Tab; Drug: Candemore Plus Tab

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym Univ. Medical Center
  • Daegu, Korea, Republic of
    • Daegu Catholic Univ. Medical Center
  • Goyang-si, Korea, Republic of
    • Myongji Hospital
  • Ilsan-gu, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Jeju, Korea, Republic of
    • Jeju National University Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Medical Center
  • Seoul, Korea, Republic of
    • SNU Boramae Medical Center
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of
    • Hallym University Kangnam Sacred Heart Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wŏnju, Korea, Republic of
    • WonJu Severance Christian Hospital
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A	Drug: Cantabell Tab; Patients assigned to experimental group are treated with Cantabell Tab
ACTIVE_COMPARATOR: B	Drug: Candemore Plus Tab; Patients assigned to experimental group are treated with Candemore Plus Tab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cSBP(central Systolic Blood Pressure)	Average cSBP change after 8 weeks compared to baseline	change after 8 weeks compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cDBP(central Diastolic Blood Pressure)	Average cDBP change after 8 weeks compared to baseline	change after 8 weeks compared to baseline
sitSBP(sitting Systolic Blood Pressure)	Average sitSBP change after 8 weeks compared to baseline	change after 8 weeks compared to baseline
sitDBP(sitting Diastolic Blood Pressure)	Average sitDBP change after 8 weeks compared to baseline	change after 8 weeks compared to baseline

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2017
• Primary Completion (ACTUAL): January 28, 2020
• Study Completion (ACTUAL): June 3, 2020

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (ACTUAL): August 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 244HT16025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No