Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897868
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Hypertension Drug: HCP1803 Drug: Amlodipine Drug: Losartan Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
Estimated Study Start Date : April 4, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental 1
HCP1803 High
Drug: HCP1803
HCP1803

Drug: Placebo
Placebo

Experimental: Experimental 2
HCP1803 Middle
Drug: HCP1803
HCP1803

Drug: Placebo
Placebo

Experimental: Experimental 3
HCP1803 Low
Drug: HCP1803
HCP1803

Drug: Placebo
Placebo

Active Comparator: Active Comparator 1
HGP0904 High
Drug: Amlodipine
Amlodipine

Active Comparator: Active Comparator 2
HGP0904 Low
Drug: Amlodipine
Amlodipine

Drug: Placebo
Placebo

Active Comparator: Active Comparator 3
HGP0608
Drug: Losartan
Losartan

Drug: Placebo
Placebo

Placebo Comparator: Placebo Comparator
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline in sitting systolic blood pressure [ Time Frame: baseline, 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in sitting systolic blood pressure [ Time Frame: baseline, 4 weeks ]
  2. Change from baseline in sitting distolic blood pressure [ Time Frame: baseline, 4 weeks, 8 weeks ]
  3. Proportion of subjects achieving blood pressure control [ Time Frame: 4 weeks, 8 weeks ]
    sitSBP/sitDBP < 140/90 mmHg

  4. Proportion of responder [ Time Frame: baseline, 4 weeks, 8 weeks ]
    Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg

  5. Change from baseline in pulse pressure(sitSBP - sitDBP) [ Time Frame: baseline, 4 weeks, 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897868


Contacts
Layout table for location contacts
Contact: Jin-A Jung, Ph.D. 82-2-410-9038 jajung@hanmi.co.kr

Locations
Layout table for location information
Korea, Republic of
Donggguk University Ilsan Hospital Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
Contact: Moo-Yong Rhee, M.D., Ph.D.    82-31-961-5775      
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Layout table for investigator information
Principal Investigator: Moo-Yong Rhee, M.D., Ph.D. Donggguk University Ilsan Hospital

Layout table for additonal information
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT03897868     History of Changes
Other Study ID Numbers: HM-APOLLO-201
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists