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
Verified date | August 2020 |
Source | Chong Kun Dang Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Chong Kun Dang Pharmaceutical |
Korea, Republic of,
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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