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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

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ClinicalTrials.gov Identifier: NCT04074551
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemias Drug: HCP1701 Drug: Losartan Drug: Amlodipine Drug: Rosuvastatin and Ezetimibe Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 16, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
HCP1701
Drug: HCP1701
HCP1701

Active Comparator: Active Comparator 1
HGP0904, HGP0608
Drug: Losartan
Losartan

Drug: Amlodipine
Amlodipine

Active Comparator: Active Comparator 2
HGP0608, HCP1306
Drug: Losartan
Losartan

Drug: Rosuvastatin and Ezetimibe
Rosuvastatin and Ezetimibe




Primary Outcome Measures :
  1. Change from baseline in LDL-C (%) [ Time Frame: baseline, 8 weeks ]
    Experimental, Active Control 1

  2. Change from baseline in sitting systolic blood pressure [ Time Frame: baseline, 8 weeks ]
    Experimental, Active Control 2


Secondary Outcome Measures :
  1. Change from baseline in LDL-C (%) [ Time Frame: baseline, 8 weeks ]
    Experimental, Active Control 2

  2. Change from baseline in sitting systolic blood pressure [ Time Frame: baseline, 8 weeks ]
    Experimental, Active Control 1

  3. Change from baseline in LDL-C (%) [ Time Frame: baseline, 4 weeks ]
  4. Change from baseline in sitting systolic blood pressure [ Time Frame: baseline, 4 weeks ]
  5. Change from baseline in TC, HDL-C, TG (%) [ Time Frame: baseline, 4 weeks, 8 weeks ]
  6. Change from baseline in sitting distolic blood pressure [ Time Frame: baseline, 4 weeks, 8 weeks ]
  7. Proportion of subject achieving LDL-C control [ Time Frame: baseline, 4 weeks, 8 weeks ]
  8. Proportion of subjects achieving blood pressure control [ Time Frame: baseline, 4 weeks, 8 weeks ]
  9. Proportion of responder for blood pressure [ Time Frame: baseline, 4 weeks, 8 weeks ]
  10. Proportion of subject achieving both LDL-C and blood pressure control [ Time Frame: baseline, 4 weeks, 8 weeks ]


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

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): NCT04074551


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

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Seoul-si, Korea, Republic of, 03080
Contact: Hyo-Soo Kim, M.D., Ph.D.         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Hyo-Soo Kim, M.D., Ph.D Seoul National University Hospital

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04074551     History of Changes
Other Study ID Numbers: HM-AMOS-301
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Losartan
Amlodipine
Rosuvastatin Calcium
Ezetimibe
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists