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A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia

Primary Purpose

Hypertension, Dyslipidemias

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP1701
Losartan
Amlodipine
Rosuvastatin and Ezetimibe
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 19
  • Patients who understood the contents and purpose of this trial and signed informed consent form
  • Patients with essential hypertension and dyslipidemia

Exclusion Criteria:

  • Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
  • Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
  • Concomitant administration of cyclosporine
  • Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
  • Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers
  • Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
  • CPK normal range > 2 times
  • Secondary hypertension and suspected secondary hypertension
  • Orthostatic hypotension with symptoms
  • Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
  • Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
  • Active gout or hyperuricemia(uric acid ≥ 9mg/dL)
  • IDDM or uncontrolled type 2 diabetes mellitus (HbA1c > 9%)
  • Ventricular arrhythmia

  • Medical history

    • Severe heart disease(heart failure of NYHA class III-IV)
    • Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA)
    • Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve
    • Ischemic heart disease(myocardial infarction, angina) within 6months
    • Angioplasty or coronary artery bypass graft(CABG) surgery within 6months

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Experimental

Active Comparator 1

Active Comparator 2

Arm Description

HCP1701

HGP0904, HGP0608

HGP0608, HCP1306

Outcomes

Primary Outcome Measures

Change from baseline in LDL-C (%)
Experimental, Active Control 1
Change from baseline in sitting systolic blood pressure
Experimental, Active Control 2

Secondary Outcome Measures

Change from baseline in LDL-C (%)
Experimental, Active Control 2
Change from baseline in sitting systolic blood pressure
Experimental, Active Control 1
Change from baseline in LDL-C (%)
Change from baseline in sitting systolic blood pressure
Change from baseline in TC, HDL-C, TG (%)
Change from baseline in sitting distolic blood pressure
Proportion of subject achieving LDL-C control
Proportion of subjects achieving blood pressure control
Proportion of responder for blood pressure
Proportion of subject achieving both LDL-C and blood pressure control

Full Information

First Posted
August 29, 2019
Last Updated
November 26, 2020
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04074551
Brief Title
A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
Official Title
A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
HCP1701
Arm Title
Active Comparator 1
Arm Type
Active Comparator
Arm Description
HGP0904, HGP0608
Arm Title
Active Comparator 2
Arm Type
Active Comparator
Arm Description
HGP0608, HCP1306
Intervention Type
Drug
Intervention Name(s)
HCP1701
Intervention Description
HCP1701
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
Losartan
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin and Ezetimibe
Intervention Description
Rosuvastatin and Ezetimibe
Primary Outcome Measure Information:
Title
Change from baseline in LDL-C (%)
Description
Experimental, Active Control 1
Time Frame
baseline, 8 weeks
Title
Change from baseline in sitting systolic blood pressure
Description
Experimental, Active Control 2
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in LDL-C (%)
Description
Experimental, Active Control 2
Time Frame
baseline, 8 weeks
Title
Change from baseline in sitting systolic blood pressure
Description
Experimental, Active Control 1
Time Frame
baseline, 8 weeks
Title
Change from baseline in LDL-C (%)
Time Frame
baseline, 4 weeks
Title
Change from baseline in sitting systolic blood pressure
Time Frame
baseline, 4 weeks
Title
Change from baseline in TC, HDL-C, TG (%)
Time Frame
baseline, 4 weeks, 8 weeks
Title
Change from baseline in sitting distolic blood pressure
Time Frame
baseline, 4 weeks, 8 weeks
Title
Proportion of subject achieving LDL-C control
Time Frame
baseline, 4 weeks, 8 weeks
Title
Proportion of subjects achieving blood pressure control
Time Frame
baseline, 4 weeks, 8 weeks
Title
Proportion of responder for blood pressure
Time Frame
baseline, 4 weeks, 8 weeks
Title
Proportion of subject achieving both LDL-C and blood pressure control
Time Frame
baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 19 Patients who understood the contents and purpose of this trial and signed informed consent form Patients with essential hypertension and dyslipidemia Exclusion Criteria: Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg Concomitant administration of cyclosporine Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin CPK normal range > 2 times Secondary hypertension and suspected secondary hypertension Orthostatic hypotension with symptoms Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times) Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times) Active gout or hyperuricemia(uric acid ≥ 9mg/dL) IDDM or uncontrolled type 2 diabetes mellitus (HbA1c > 9%) Ventricular arrhythmia Medical history Severe heart disease(heart failure of NYHA class III-IV) Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA) Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve Ischemic heart disease(myocardial infarction, angina) within 6months Angioplasty or coronary artery bypass graft(CABG) surgery within 6months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-si
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia

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