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

• Status: Completed
• Trial end date: 2020-03-17
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Amlodipine; Ezetimibe; Losartan; Rosuvastatin Calcium

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