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NCT04521023 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04521023
Other study ID # 244HT16025
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 20, 2017
Est. completion date June 3, 2020

Study information
Verified date August 2020
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date June 3, 2020
Est. primary completion date January 28, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cantabell Tab
Patients assigned to experimental group are treated with Cantabell Tab
• Candemore Plus Tab
Patients assigned to experimental group are treated with Candemore Plus Tab

Locations
Country Name City State
Korea, Republic of Hallym Univ. Medical Center Anyang
Korea, Republic of Daegu Catholic Univ. Medical Center Daegu
Korea, Republic of MYONGJI Hospital Goyang-si
Korea, Republic of Inje University Ilsan Paik Hospital Ilsan-gu
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Jeju National University Hospital Jeju
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Hallym University Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Hanyang University Medical Center Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of SNU Boramae Medical Center Seoul
Korea, Republic of Ajou University Hospital Suwon Gyeonggi-do
Korea, Republic of Ulsan University Hospital Ulsan
Korea, Republic of Wonju Severance Christian Hospital Wonju

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary cSBP(central Systolic Blood Pressure) Average cSBP change after 8 weeks compared to baseline change after 8 weeks compared to baseline
Secondary cDBP(central Diastolic Blood Pressure) Average cDBP change after 8 weeks compared to baseline change after 8 weeks compared to baseline
Secondary sitSBP(sitting Systolic Blood Pressure) Average sitSBP change after 8 weeks compared to baseline change after 8 weeks compared to baseline
Secondary sitDBP(sitting Diastolic Blood Pressure) Average sitDBP change after 8 weeks compared to baseline change after 8 weeks compared to baseline
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