A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: HCP1803; Drug: Amlodipine; Drug: Losartan; Drug: Placebo

• Registration Number: NCT03897868
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-21
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-01
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 1, Visit 2

Exclusion Criteria

• Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
• Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2
• Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2
• Patient with secondary hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 1	Placebo	HCP1803 High
Experimental 1	HCP1803	HCP1803 High
Active Comparator 2	Placebo	HGP0904 Low
Active Comparator 3	Placebo	HGP0608
Placebo Comparator	Placebo	Placebo
Experimental 3	Placebo	HCP1803 Low
Experimental 2	HCP1803	HCP1803 Middle
Experimental 2	Placebo	HCP1803 Middle
Experimental 3	HCP1803	HCP1803 Low
Active Comparator 1	Amlodipine	HGP0904 High
Active Comparator 3	Losartan	HGP0608
Active Comparator 2	Amlodipine	HGP0904 Low

Primary Outcome Measures

Name	Time	Method
Change from baseline in sitting systolic blood pressure	baseline, 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in sitting systolic blood pressure	baseline, 4 weeks
Proportion of responder	baseline, 4 weeks, 8 weeks	Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg
Change from baseline in pulse pressure(sitSBP - sitDBP)	baseline, 4 weeks, 8 weeks
Proportion of subjects achieving blood pressure control	4 weeks, 8 weeks	sitSBP/sitDBP \< 140/90 mmHg
Change from baseline in sitting distolic blood pressure	baseline, 4 weeks, 8 weeks

Trial Locations

Locations (1)

Donggguk University Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of