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Completed

NCT Number: NCT04074551

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP1701

Drug

HCP1701

Losartan

Drug

Losartan

Amlodipine

Drug

Amlodipine

Rosuvastatin and Ezetimibe

Drug

Rosuvastatin and Ezetimibe

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2019
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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