- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897868
A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension (HM_APOLLO)
July 12, 2022 updated by: Hanmi Pharmaceutical Company Limited
A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
248
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
- Donggguk University Ilsan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental 1
HCP1803 High
|
Placebo
HCP1803
|
Experimental: Experimental 2
HCP1803 Middle
|
Placebo
HCP1803
|
Experimental: Experimental 3
HCP1803 Low
|
Placebo
HCP1803
|
Active Comparator: Active Comparator 1
HGP0904 High
|
Amlodipine
|
Active Comparator: Active Comparator 2
HGP0904 Low
|
Placebo
Amlodipine
|
Active Comparator: Active Comparator 3
HGP0608
|
Placebo
Losartan
|
Placebo Comparator: Placebo Comparator
Placebo
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in sitting systolic blood pressure
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in sitting systolic blood pressure
Time Frame: baseline, 4 weeks
|
baseline, 4 weeks
|
|
Change from baseline in sitting distolic blood pressure
Time Frame: baseline, 4 weeks, 8 weeks
|
baseline, 4 weeks, 8 weeks
|
|
Change from baseline in pulse pressure(sitSBP - sitDBP)
Time Frame: baseline, 4 weeks, 8 weeks
|
baseline, 4 weeks, 8 weeks
|
|
Proportion of subjects achieving blood pressure control
Time Frame: 4 weeks, 8 weeks
|
sitSBP/sitDBP < 140/90 mmHg
|
4 weeks, 8 weeks
|
Proportion of responder
Time Frame: baseline, 4 weeks, 8 weeks
|
Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg
|
baseline, 4 weeks, 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Moo-Yong Rhee, M.D., Ph.D., Donggguk University Ilsan Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2019
Primary Completion (Actual)
February 26, 2020
Study Completion (Actual)
February 26, 2020
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
March 29, 2019
First Posted (Actual)
April 1, 2019
Study Record Updates
Last Update Posted (Actual)
July 14, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Losartan
Other Study ID Numbers
- HM-APOLLO-201
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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