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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074551
• Other study ID #: HM-AMOS-301
• Status: Completed
• Phase: Phase 3
• Start date: July 16, 2019
• Est. completion date: March 17, 2020

Study information

• Verified date: November 2020
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• HCP1701
HCP1701
• Losartan
Losartan
• Amlodipine
Amlodipine
• Rosuvastatin and Ezetimibe
Rosuvastatin and Ezetimibe

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-si

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in LDL-C (%)	Experimental, Active Control 1	baseline, 8 weeks
Primary	Change from baseline in sitting systolic blood pressure	Experimental, Active Control 2	baseline, 8 weeks
Secondary	Change from baseline in LDL-C (%)	Experimental, Active Control 2	baseline, 8 weeks
Secondary	Change from baseline in sitting systolic blood pressure	Experimental, Active Control 1	baseline, 8 weeks
Secondary	Change from baseline in LDL-C (%)		baseline, 4 weeks
Secondary	Change from baseline in sitting systolic blood pressure		baseline, 4 weeks
Secondary	Change from baseline in TC, HDL-C, TG (%)		baseline, 4 weeks, 8 weeks
Secondary	Change from baseline in sitting distolic blood pressure		baseline, 4 weeks, 8 weeks
Secondary	Proportion of subject achieving LDL-C control		baseline, 4 weeks, 8 weeks
Secondary	Proportion of subjects achieving blood pressure control		baseline, 4 weeks, 8 weeks
Secondary	Proportion of responder for blood pressure		baseline, 4 weeks, 8 weeks
Secondary	Proportion of subject achieving both LDL-C and blood pressure control		baseline, 4 weeks, 8 weeks