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

Phase 3

Completed

• Conditions: Hypertension; Dyslipidemias
• Interventions: Drug: HCP1701; Drug: Losartan; Drug: Rosuvastatin and Ezetimibe; Drug: Amlodipine

• Registration Number: NCT04074551
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-16
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-29
• Study First Posted: 2019-08-30
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-17
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator 2	Rosuvastatin and Ezetimibe	HGP0608, HCP1306
Experimental	HCP1701	HCP1701
Active Comparator 1	Losartan	HGP0904, HGP0608
Active Comparator 1	Amlodipine	HGP0904, HGP0608
Active Comparator 2	Losartan	HGP0608, HCP1306

Primary Outcome Measures

Name	Time	Method
Change from baseline in LDL-C (%)	baseline, 8 weeks	Experimental, Active Control 1
Change from baseline in sitting systolic blood pressure	baseline, 8 weeks	Experimental, Active Control 2

Secondary Outcome Measures

Name	Time	Method
Change from baseline in sitting distolic blood pressure	baseline, 4 weeks, 8 weeks
Change from baseline in sitting systolic blood pressure	baseline, 4 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
Change from baseline in TC, HDL-C, TG (%)	baseline, 4 weeks, 8 weeks
Proportion of subject achieving both LDL-C and blood pressure control	baseline, 4 weeks, 8 weeks
Change from baseline in LDL-C (%)	baseline, 4 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Seoul-si, Korea, Republic of