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

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

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 Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemias
• Intervention / Treatment: Drug: Amlodipine; Drug: Losartan; Drug: HCP1701; Drug: Rosuvastatin and Ezetimibe

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul-si
    • Seoul, Seoul-si, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; HCP1701	Drug: HCP1701; HCP1701
ACTIVE_COMPARATOR: Active Comparator 1; HGP0904, HGP0608	Drug: Amlodipine; Amlodipine; Drug: Losartan; Losartan
ACTIVE_COMPARATOR: Active Comparator 2; HGP0608, HCP1306	Drug: Losartan; Losartan; Drug: Rosuvastatin and Ezetimibe; Rosuvastatin and Ezetimibe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in LDL-C (%)	Experimental, Active Control 1	baseline, 8 weeks
Change from baseline in sitting systolic blood pressure	Experimental, Active Control 2	baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in sitting systolic blood pressure		baseline, 4 weeks
Change from baseline in sitting distolic blood pressure		baseline, 4 weeks, 8 weeks
Change from baseline in LDL-C (%)	Experimental, Active Control 2	baseline, 8 weeks
Change from baseline in sitting systolic blood pressure	Experimental, Active Control 1	baseline, 8 weeks
Change from baseline in LDL-C (%)		baseline, 4 weeks
Change from baseline in TC, HDL-C, TG (%)		baseline, 4 weeks, 8 weeks
Proportion of subject achieving LDL-C control		baseline, 4 weeks, 8 weeks
Proportion of subjects achieving blood pressure control		baseline, 4 weeks, 8 weeks
Proportion of responder for blood pressure		baseline, 4 weeks, 8 weeks
Proportion of subject achieving both LDL-C and blood pressure control		baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Hyo-Soo Kim, M.D., Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2019
• Primary Completion (ACTUAL): March 17, 2020
• Study Completion (ACTUAL): March 17, 2020

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (ACTUAL): August 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Rosuvastatin Calcium; Losartan; Ezetimibe
• Other Study ID Numbers: HM-AMOS-301

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