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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: Losartan; Drug: HCP1701; Drug: Rosuvastatin and Ezetimibe; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04074551

HM-AMOS-301

Details and patient eligibility

About

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

Enrollment: 145 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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145 participants in 3 patient groups

Experimental

Experimental group

Description:

HCP1701

Treatment:

Drug: HCP1701

Active Comparator 1

Active Comparator group

Description:

HGP0904, HGP0608

Treatment:

Drug: Losartan

Drug: Amlodipine

Active Comparator 2

Active Comparator group

Description:

HGP0608, HCP1306

Treatment:

Drug: Losartan

Drug: Rosuvastatin and Ezetimibe